RegenKit®-THT-1/RegenCell®

GUDID 07640138980244

REGEN LAB SA

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 07640138980244
• NIH Device Record Key: 922375c6-e172-43a4-99df-e1d8ea346cfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RegenKit®-THT-1/RegenCell®
• Version Model Number: RK-THT-1
• Company DUNS: 482206518
• Company Name: REGEN LAB SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640138980244 [Primary]

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-25
• Device Publish Date: 2019-06-17

Devices Manufactured by REGEN LAB SA

• 07640138981012 - RegenET: 2022-07-06 Kit containing 20 x R-ET-3 in a carton box
• 07640138981630 - RegenKit-BCT-3 (20ml)/RegenPlasma: 2022-04-11 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 - RegenET: 2020-03-03
• 07640138980244 - RegenKit®-THT-1/RegenCell®: 2019-06-25
• 07640138980244 - RegenKit®-THT-1/RegenCell®: 2019-06-25
• 07640138980251 - RegenKit®-THT-4/RegenCell®: 2019-06-25
• 07640138980565 - RegenKit®-THT-2/RegenCell®: 2019-06-25