Wound Care Accessory Set

GUDID 00850033131123

Regenlab USA LLC

Blood collection set, invasive

• Primary Device ID: 00850033131123
• NIH Device Record Key: a0c818a5-bc65-41d4-9104-00c916208e83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wound Care Accessory Set
• Version Model Number: WCA-SET1
• Company DUNS: 087434117
• Company Name: Regenlab USA LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00850033131123 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-18
• Device Publish Date: 2025-08-08

Devices Manufactured by Regenlab USA LLC

• 00850033131116 - Enhanced HA: 2025-09-08
• 00850033131123 - Wound Care Accessory Set: 2025-08-18
• 00850033131123 - Wound Care Accessory Set: 2025-08-18
• 00850033131109 - RegenLab USA: 2024-04-26 RegenKit-THT-BMC, Ref: RK-THT-BMC-3-10
• 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