Home GUDID 04046955096763
Subcutaneous Injection Supply Kit
Primary DI 04046955096763
Brand Subcutaneous Injection Supply Kit
Company B. Braun Melsungen Aktiengesellschaft
Model 900-V1US01
Device description The parenteral administration kit is composed to support the home application of a subcutaneous injection of fluids for medical purposes.
Published 2017-08-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name POR Parenteral Administration Kit
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class POR Parenteral Administration Kit General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04046955096763 Package GS1 6 In Commercial Distribution 04046955096756 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04046955096763 04046955096763 4046955096763 04046955096756 04046955096756 4046955096756
GMDN Terms# Term, Definition table Term Definition Hypodermic needle, single-use A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 315016972 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04046955251704 Subcutaneous Injection Supply Kit 2 B. Braun Melsungen Aktiengesellschaft POR 2018-09-03 04046955251711 Subcutaneous Injection Supply Kit 2 B. Braun Melsungen Aktiengesellschaft POR 2018-09-03 04046955096756 Subcutaneous Injection Supply Kit B. Braun Melsungen Aktiengesellschaft POR 2017-08-07