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510(k) Data Aggregation
K Number
K240039Device Name
Enteral Feeding Sets
Manufacturer
Date Cleared
2024-04-17
(103 days)
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Primecare Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a EnPlus spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults.
Device Description
The Enteral Feeding Sets have four models, Enteral Feeding Pump bag Set, Enteral Feeding Pump EnPlus spike Set, Enteral Feeding Gravity bag Set, Enteral Feeding Gravity EnPlus spike Set. The Enteral Feeding Pump bag Set and Enteral Feeding Gravity bag Set both have a structure of a formula bag with 100ml graduations and a protective closure cap. The difference is the former is droved by pump and the latter is droved by gravity. Enteral Feeding Pump EnPlus spike Set and Enteral Feeding Gravity EnPlus spike Set feature a piercing spike (with or without screw cap) used to connect the set to a prefilled container of enteral feeding solution. It is a single-use, non-sterile device.
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K Number
K202698Device Name
Prefilled Syringe
Manufacturer
Date Cleared
2020-12-15
(90 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Primecare Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 10cc and 30cc pre-filled syringes are intended to be used for foley catheter balloon inflation.
Device Description
The device is a single-use 10cc and 30cc syringe pre-filled with USP purified water and gamma irradiated. The device has two models, PCAA01 and PCAA03. They are only different in volume; PCAA01 is 10cc, and PCAA03 is 30cc. The syringe is produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and protect cap. The device contacts indirectly with the human body. The duration of contact is less than 24 hours. The product is used in conjunction with the urinary catheter to push the plunger of the syringe to inject the sterilized pre-filled purified water into the balloon of the urinary catheter to inflate the balloon.
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