Search Results
Found 1 results
510(k) Data Aggregation
K Number
K133077Device Name
GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET
Manufacturer
GENERICA MEDICAL INTERNATIONAL, INC.
Date Cleared
2014-07-28
(301 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
GENERICA MEDICAL INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Enteral Feeding Sets are intended to dispense liguid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the passess feeding tube and may asse gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets may include a hag to contain the feeding solution and/or spike to a pre-filled container.
Device Description
The Generica Medical International's line of Enteral Feeding Sets consists of the following:
- Generica Medical Enteral Delivery Pump Bag Set, 1.
- Generica Medical Enteral Delivery Pump Spike Set, 2.
- ે. Generica Medical Enteral Delivery Gravity Bag Set
The Generica Medical Enteral Delivery Pump Spike Set with the Cross Spike Connector is compatible with SpikeRight® and SpikeRight® enteral feeding systems.
The Generica Medical Enteral Delivery Pump Bag Set has a twist cap. The vinyl bag features a rigid wide-mouth angled funnel opening that makes pouring easv and helps prevent spills and waste. The 1000 mL formula vinvi bag has 50 mL graduations to make it easier for reading and better accuracy when filling.
The Generica Medical Enteral Delivery Gravity Bag Set has a twist cap. The vinyl bag features a rigid wide-mouth angled funnel opening that makes pouring easy and helps prevent spills and waste. Bag graduations are in 50 mL increments for easier readings and allow for better accuracy when filling
Ask a Question
Page 1 of 1