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510(k) Data Aggregation
K Number
K220955Device Name
Hudson RCI Variable concentration Large Volume Nebulizer (1770)
Manufacturer
Medline Industires, Inc.
Date Cleared
2023-06-23
(448 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
Medline Industires, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The non-prefilled nebulizer is indicated for use when humidity needs to the air flow going to a patient in the form of an aerosol. The large volume nebulizer also allows for the provision of humidified oxygen at select oxygen concentrations from 28% to 98%. This product is for single patient use and is designed to be used in hospital, nursing homes, extended care facilities, outpatient clinics as prescribed by a healthcare professional.
Device Description
The large volume nebulizer is a non-prefilled reservoir nebulizer for supplying humidity for inhalation therapy. The device features a wing nut style connector that fits standard flow metered medical gas sources and includes a 500mL capacity jar with minimum and maximum fill lines. Large volume nebulize an internal venturi nozzle to draw the solution up from the jar through a small plastic pickup tube and into the gas stream to be aerosolized. A rotating collar sets the delivered oxygen concentration by controlling the size of the room air opening around the venturi. A bull-nose style output connector is used to connect 22mm aerosol tubing for delivery to the patient.
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K Number
K201129Device Name
Medline Smoke Evacuation Pencil
Manufacturer
Medline Industires, Inc.
Date Cleared
2020-10-16
(171 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Medline Industires, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medline's Smoke Evacuation Pencil is designed for general electrosurgical applications including cutting and coagulating, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
Device Description
Not Found
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K Number
K201390Device Name
Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
Manufacturer
Medline Industires, Inc.
Date Cleared
2020-09-18
(114 days)
Product Code
LZC, LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Medline Industires, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
The Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) are single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, light blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.
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K Number
K200960Device Name
Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)
Manufacturer
Medline Industires, Inc.
Date Cleared
2020-07-13
(94 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Medline Industires, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
The Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy drugs) are nonsterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are dark blue, powder free, nitrile ambidextrous gloves with a beaded cuff. The gloves are offered in sizes small, medium, large, and extra extra extra large packaged in a chipboard box.
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K Number
K201319Device Name
Medline UNITE Jones Fracture Screw System
Manufacturer
Medline Industires, Inc.
Date Cleared
2020-06-17
(30 days)
Product Code
HWC, HTN
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Medline Industires, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medline UNITE® Jones Fracture Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion and repair and fixation of mal-unions, acute fractures, avulsion fractures, and repetitive stress fractures for bones appropriate for the size of the device including the fifth metatarsal (Jones fracture). Screws are intended for single use only.
Device Description
The Medline UNITE® Jones Fracture Screws are manufactured from titanium alloy. The screws are offered in various diameters ranging from 4.5mm up to 6.0mm and overall lengths ranging from 34mm up to 65mm with consistent thread lengths.
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