CeaLogic Specimen Collection Kit

Basic Information

• Brand Name: CeaLogic Specimen Collection Kit
• Primary DI: 00861092002613
• Version / Model: 2701
• Company Name: RECIBIO, INC.
• Labeler DUNS: 081273312
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-01
• Public Version: 1
• Public Version Date: 2026-03-09
• Public Version Status: New
• Public Device Record Key: 4b33a020-34ad-4997-899a-b144e801e044

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYZ	Trap, Sterile Specimen	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14189	Culture tube	A sterile glass or plastic tube-like container used to hold a culture specimen. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00861092002613	GS1
Package	10861092002610	GS1	Case	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]