RegenKit®-BCT-3

GUDID 07640138980411

REGEN LAB SA

Haematological concentrate system preparation kit, platelet concentration
Primary Device ID07640138980411
NIH Device Record Keya635ae12-87e7-48d8-9bca-17082e816faf
Commercial Distribution StatusIn Commercial Distribution
Brand NameRegenKit®-BCT-3
Version Model NumberRK-BCT-3
Company DUNS482206518
Company NameREGEN LAB SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
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
GS107640138980411 [Primary]

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-09
Device Publish Date2016-09-15

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
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

Trademark Results [RegenKit]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REGENKIT
REGENKIT
79062709 3718804 Live/Registered
RegenLab USA LLC
2008-09-19

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