RegenLab USA

GUDID 00850033131109

RegenKit-THT-BMC, Ref: RK-THT-BMC-3-10

Regenlab USA LLC

Blood collection set, noninvasive

• Primary Device ID: 00850033131109
• NIH Device Record Key: 27c31d50-749a-44b7-bbc9-1ff0c811dbc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RegenLab USA
• Version Model Number: RK-THT-BMC-3-10
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033131109 [Primary]

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: 2024-04-26
• Device Publish Date: 2024-04-18

On-Brand Devices [RegenLab USA]

• 00850033131086: R-ET
• 00850033131079: RK-WG-2
• 00850033131062: RK-THT-3-20-U
• 00850033131055: RK-THT-3-U
• 00850033131048: RK-BCT-3-20-U
• 00850033131031: RK-BCT-3-U
• 00850033131109: RegenKit-THT-BMC, Ref: RK-THT-BMC-3-10