CeaLogic Specimen Collection Kit

GUDID 00861092002613

Specimen collection Kit for the collection of a specimen in a hospital or surgical setting.

RECIBIO, INC.

Culture tube

• Primary Device ID: 00861092002613
• NIH Device Record Key: 4b33a020-34ad-4997-899a-b144e801e044
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CeaLogic Specimen Collection Kit
• Version Model Number: 2701
• Company DUNS: 081273312
• Company Name: RECIBIO, INC.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-8447324246
• Email: customercare@recibio.us
• Phone: 1-8447324246
• Email: customercare@recibio.us
• Phone: 1-8447324246
• Email: customercare@recibio.us
• Phone: 1-8447324246
• Email: customercare@recibio.us
• Phone: 1-8447324246
• Email: customercare@recibio.us
• Phone: 1-8447324246
• Email: customercare@recibio.us
• Phone: 1-8447324246
• Email: customercare@recibio.us
• Phone: 1-8447324246
• Email: customercare@recibio.us
• Phone: 1-8447324246
• Email: customercare@recibio.us
• Phone: 1-8447324246
• Email: customercare@recibio.us
• Phone: 1-8447324246
• Email: customercare@recibio.us
• Phone: 1-8447324246
• Email: customercare@recibio.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861092002613 [Primary]
GS1	10861092002610 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• BYZ: Trap, Sterile Specimen

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: 2026-03-09
• Device Publish Date: 2026-03-01

Devices Manufactured by RECIBIO, INC.

• 00861092002606 - CeaLogic Ratio Applicator Kit: 2026-03-09
• 00861092002613 - CeaLogic Specimen Collection Kit: 2026-03-09Specimen collection Kit for the collection of a specimen in a hospital or surgical setting.
• 00861092002613 - CeaLogic Specimen Collection Kit: 2026-03-09 Specimen collection Kit for the collection of a specimen in a hospital or surgical setting.
• 00861092002637 - Cealogic Ribbon: 2026-03-09 Advanced support matrix for enhanced closure integrity
• 00861092002644 - Cealogic Film: 2026-03-09 Protective barrier for optimal healing environment