Home GUDID 04046955096756 Subcutaneous Injection Supply Kit
Primary DI 04046955096756
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 Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 Not 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 Premarket exempt true Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00198815000152 Takeda Convenience Kit Takeda Pharmaceuticals U.S.A., Inc. POR 2026-07-28 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 04046955096763 Subcutaneous Injection Supply Kit B. Braun Melsungen Aktiengesellschaft POR 2017-08-07
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