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510(k) Data Aggregation

    K Number
    K221154
    Device Name
    Infant Heel WarmerTM; Heel Snuggler®
    Manufacturer
    International Biomedical
    Date Cleared
    2022-10-07

    (169 days)

    Product Code
    MPO
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    MPO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infant Heel Warmer™ Heel Snuggler® are instant warm packs intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, nontoxic, non-sterile, disposable device. The Infant Heel Warmer™, Heel Snuggle® have two configurations, the Heel Snuggler®, which is designed to conform to the shape of the infant's heel, and the standard Infant Heel Warmer™. The devices are primarily used in hospitals, Doctor's offices, and other healthcare settings.
    Device Description
    The Infant Heel Warmer™/Heel Snuggler® is a single use, disposable pouch that is filled with a super saturated solution of food grade sodium acetate and a catalyst disk. When the catalyst disk inside the packet is flexed by the user, the catalyst disk reacts with the non-toxic solution and initiates a chemical exothermic crystallization of the sodium acetate, generating heat. When activated at 75°F, both models will reach between 104-107°F and then gradually decrease in temperature over time. The Heel Snuggler® is a butterfly shape with two straps and the Infant Heel Warmer™ is rectangular with one strap. Straps with adhesive ends are attached to the packet for securing the heel warmer to the infant's foot, if desired. Immediately following activation of the user rests the bottom of the infant's foot on one portion of the packet and holds the other portion of the packet to the ankle. The straps with adhesive tape on the end are then fitted across the infant's foot and ankle and secured to the opposite side of the adhesive portion of the strap is affixed to the packet only, not the infant's skin. The straps on the heel warmer are perforated, which enables the user to easily tear the straps and remove the heel warmer from the infant's foot after use.
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    K Number
    K151845
    Device Name
    Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
    Manufacturer
    COOPERSURGICAL, INC.
    Date Cleared
    2016-03-18

    (255 days)

    Product Code
    MPO
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    MPO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, non-sterile, disposable warmer.
    Device Description
    The CooperSurgical Infant Heel Warmer, which is available in both a liquid version (The Infant Heel Warmer, Model 24401) and a gel version (WarmGel® Infant Heel Warmer, Model 20418), is a non-sterile, single-use, disposable device comprised of a biaxially oriented nylon (BON)/polyethylene outer pouch filled with a supersaturated solution of food grade sodium acetate and water (liquid version), or food grade sodium acetate, water, and hydroxyethylcellulose, a common thickener (gel version). An adhesive tape is attached to the pouch, which can hold the warmer in place if desired. The pouch also contains a stainless steel disc that, when flexed, initiates an exothermic crystallization of the sodium acetate, generating heat. When activated at 75° + 1° F, the maximum peak temperature of the CooperSurgical Infant Heel Warmer is 107° F, which is reached in approximately 40 seconds and then gradually decreases over time.
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    K Number
    K150627
    Device Name
    Rapid Aid Instant Disposable Infant Heel Warmer
    Manufacturer
    RAPID AID CORP.
    Date Cleared
    2015-05-27

    (77 days)

    Product Code
    MPO
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    MPO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rapid Aid Infant Heel Warmer is primarily used in hospitals, doctor's offices, and other healthcare facilities. It is an instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, non-sterile, disposable warmer.
    Device Description
    The Rapid Aid Infant Heel Warmer is a self contained unit comprised of a flexible, poly/nylon outer pouch containing: - a) A metal disc that can be flexed during activation, - b) Liquid solution of food grade sodium acetate and water, - c) Minute crystals of sodium acetate. An adhesive tape is attached to the top of the unit is activated by squeezing firmly on the inner fluid pouch, this will cause the inner perforated pouch to activate. Rapid crystallization occurs when the liquid contents are exposed to the minute crystals of sodium acetate contained within the poly/nylon outer pouch. This exothermnic reaction causes the unit to heat up to 104ºF. The adhesive tape strip is used to hold the warmer in place if desired.
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    K Number
    K103549
    Device Name
    DENOVO TEDDY GEL INFANT HEEL WARMER
    Manufacturer
    DENOVO PRODUCTS LLC
    Date Cleared
    2011-04-08

    (126 days)

    Product Code
    MPO
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    MPO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use by hospital, Ambulatory Surgery staff, Outpatient Clinics for warming of Infant's Heels prior to drawing blood for sampling or general analysis. This device is intended for Rx use only. This device is single use, non-sterile, and disposable.
    Device Description
    Not Found
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    K Number
    K053254
    Device Name
    INFANT HEEL WARMER BY INTCO
    Manufacturer
    SHANGHAI INTCO MEDICAL SUPPLY CO., LTD.
    Date Cleared
    2006-09-19

    (302 days)

    Product Code
    MPO
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    MPO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infant Heel Warmer by Intco is a single use, non-toxic, non-sterile, disposable device. It is an instant warm pack intended to be used on an infant's heel to aid in the drawing of blood for analysis. The device is to be limited to use in hospitals, doctors' offices, and other healthcare facilities that administer health care services to newborns and infants. Prescription Use Only. The Indication for use of the Infant Heel Warmer by Intco is the same to the Rapid Aid Infant Heel Warmer, a legally marketed predicate device.
    Device Description
    - Classified by FDA's Physical Medicine Device Panel as Class I, 21 CFR 890.5710, Pack, Hot or Cold disposable, MPO, and meets all requirements of ISO 7176 and EN 1021. - The Infant Heel Warmer by Intco is a self contained unit comprised of a flexible, poly/nylon outer pouch containing: I) A flexible, perforated, polyethylene/polyester inner pouch that holds the liquid solution. II) Liquid solution of food grade sodium acetate and water contained in I). III) Minute crystals of sodium acetate. An adhesive tape is attached to the top of the unit. The unit is activated by squeezing firmly on the inner fluid pouch, this will cause the inner perforated pouch to activate. Rapid crystallization occurs when the liquid contents are exposed to the minute crystals of sodium acetate contained within the poly/nylon outer pouch. This exothermic reaction causes the unit to heat up to 102 degree F. The adhesive tape strip is used to hold the warmer in place on the infant's heel.
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    K Number
    K040856
    Device Name
    RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
    Manufacturer
    RAPID AID LTD.
    Date Cleared
    2004-05-03

    (31 days)

    Product Code
    MPO
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    MPO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rapid Aid Infant Heel Warmer is primarily used in hospitals, Doctor's offices, and other healthcare facilities. It is an instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, non-sterile, disposable warmer.
    Device Description
    The Rapid Aid Infant Heel Warmer is a self contained unit comprised of a flexible, poly/nylon outer pouch containing: - a) A flexible, perforated, polyethylene/polyester inner pouch that holds the liquid solution. - b) Liquid solution of food grade sodium acetate and water contained in a). - c) Minute crystals of sodium acetate. An adhesive tape is attached to the top of the unit. The unit is activated by squeezing firmly on the inner fluid pouch, this will cause the inner perforated pouch to activate. Rapid crystallization occurs when the liquid contents are exposed to the minute crystals of sodium acetate contained within the poly/nylon outer pouch. This exothermic reaction causes the unit to heat up to 105 degrees F. The adhesive tape strip is used to hold the warmer in place on the infant's heel.
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    K Number
    K040044
    Device Name
    HEEL SNUGGLER, MODEL 99047
    Manufacturer
    RESPIRONICS, INC.
    Date Cleared
    2004-01-27

    (15 days)

    Product Code
    MPO
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    MPO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Respironics Heel Snuggler infant heel warmer is intended for use whenever circulation needs to be stimulated in the infant heel in order for blood sampling to occur.
    Device Description
    The Heel Snuggler is a butterfly shaped packet that is filled with a non-toxic solution and a catalyst disk. Two straps with adhesive ends are attached to one side of the packet for securing the heel warmer to the infant's foot. Immediately following activation of the user rests the bottom of the infant's foot on the larger portion of the packet and holds the smaller portion of the packet to the ankle. The straps with adhesive tape on the end are then fitted across the infant's foot and ankle and secured to the opposite side of the packet. The adhesive portion of the strap is affixed to the packet only, not the infant's skin. This forms a boot shape around the infant's foot. The heel warmer are perforated, which enables the user to easily tear the straps and remove the heel warmer from the infant's foot after use. When the catalyst disk inside the packet is flexed by the catalyst reachs with the solution a ri initiates a chemical exothermic reaction, which produces warmth.
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    K Number
    K032989
    Device Name
    MEDI-HEAT INFANT HEEL WARMER
    Manufacturer
    MEDIHEAT, INC.
    Date Cleared
    2003-10-22

    (28 days)

    Product Code
    MPO
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    MPO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. MediHEAT Infant Heel Warmer is primarily used in hospitals, Doctor's offices, and other healthcare facilities. 2. Normally, Medical Practitioners squeeze the heels of Infants to increase blood circulation in the area before drawing blood for analyses. 3. The Infant Heel Warmer is used to warm the heel of an Infant to increase blood circulation to the area to facilitate blood sampling.
    Device Description
    The MediHeat Infant Heel Warmer is a self-contained unit comprised of a flexible Nylon/Polyethylene bag containing the ingredients: a) Food grade sodium acetate, b) Water and c) Activator disk. When the disk is clicked, it activates the sodium acetate solution causing it to pass from the liquid phase to a solid phase (crystallization), making it exothermic. d) An adhesive tape to hold the warmer in place. It heats up to a maximum temperature of up to 105°F and gradually diminishes.
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    K Number
    K964523
    Device Name
    RECOVER INFANT HEEL WARMER (5100)
    Manufacturer
    FLORIDA MEDICAL INDUSTRIES, INC.
    Date Cleared
    1997-02-10

    (90 days)

    Product Code
    MPO
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    MPO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Recover® Infant Heel Warmer is intended to be used for warming the heel site of an infant prior to a heel stick procedure. The warmth enhances vasodilation and increases blood flow in an infant's heel to ensure adequate blood for sampling.
    Device Description
    Non Toxic, Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon /polyethylene laminate bag. Provides heat to 105°F.
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    K Number
    K961154
    Device Name
    BAXTER SODIUM ACETATE INFANT HEEL WARMER
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Date Cleared
    1996-06-06

    (76 days)

    Product Code
    MPO
    Regulation Number
    890.5710
    Why did this record match?
    Product Code :

    MPO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Baxter Sodium Acetate Infant Heel Warmer™ is a single-use, non-sterile device. It is a heat therapy pack intended to be used on an infant's heel in order to increase peripheral blood flow and oxygenation prior to blood sampling.
    Device Description
    The Baxter Sodium Acetate Infant Heel Warmer™ is comprised of a polyethylene/BON pouch enclosing the phase change chemical and the activator disk-like trigger. Upon pinching and flexing trigger also located within the pouch, aluminum oxide grit is released into the sodium acetate and water mixture thus initiating a chemical exothermic reaction. The hot pack immediately reaches a maximum temperature of 104 °F +/- 2.9 °F and gradually diminishes over time.
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