RegenKit Wound-Gel SE-RK-WG-1

GUDID 00850033131093

.

Regenlab USA LLC

Blood collection set, noninvasive

• Primary Device ID: 00850033131093
• NIH Device Record Key: d94786a4-eb6f-4145-91ff-6a42065ea024
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RegenKit Wound-Gel
• Version Model Number: RK-WG-1
• Catalog Number: SE-RK-WG-1
• Company DUNS: 087434117
• Company Name: Regenlab USA LLC
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033131093 [Primary]

FDA Product Code

• PMQ: Peripheral Blood Processing Device For Wound Management

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: 2024-03-20
• Device Publish Date: 2024-03-12

Devices Manufactured by Regenlab USA LLC

• 00850033131109 - RegenLab USA: 2024-04-26 RegenKit-THT-BMC, Ref: RK-THT-BMC-3-10
• 00850033131093 - RegenKit Wound-Gel: 2024-03-20.
• 00850033131093 - RegenKit Wound-Gel: 2024-03-20 .
• 00850033131031 - RegenLab USA: 2023-05-08
• 00850033131048 - RegenLab USA: 2023-05-08
• 00850033131055 - RegenLab USA: 2023-05-08
• 00850033131062 - RegenLab USA: 2023-05-08
• 00850033131079 - RegenLab USA: 2023-05-08
• 00850033131086 - RegenLab USA: 2023-05-08