Accessory Set

GUDID 07640138980329

REGEN LAB SA

Venous butterfly needle/set
Primary Device ID07640138980329
NIH Device Record Key324bcf58-7c0c-413a-be89-e01f681d69f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccessory Set
Version Model NumberBCA-SET3
Company DUNS482206518
Company NameREGEN LAB SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107640138980329 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-21
Device Publish Date2020-10-13

Devices Manufactured by REGEN LAB SA

07640138981012 - RegenET2022-07-06 Kit containing 20 x R-ET-3 in a carton box
07640138981630 - RegenKit-BCT-3 (20ml)/RegenPlasma2022-04-11 RegenKit-BCT-3 (20ml) containing 3 RegenBCT tubes 20 ml.
07640138981593 - RegenKit-THT-3/RegenCell®2021-11-03 RegenKit-THT-3 containing 3 x R-THT20 tubes.
07640138980329 - Accessory Set 2020-10-21
07640138980329 - Accessory Set 2020-10-21
07640138981364 - RegenET2020-03-03
07640138980244 - RegenKit®-THT-1/RegenCell®2019-06-25
07640138980251 - RegenKit®-THT-4/RegenCell®2019-06-25
07640138980565 - RegenKit®-THT-2/RegenCell®2019-06-25

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