RegenLab USA

GUDID 00850033131109

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

Regenlab USA LLC

Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive 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