Adult ECC Pack BO TOP 28903
Adult ECC Pack BO TOP 28903 (709000093) is a Class II device made by Datascope Corp., listed in FDA GUDID since 16 Feb 2016 (UDI-DI 00607567207844), not in commercial distribution (GUDID) as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00607567207844 | Date16 Feb 2016 | StatusListed |
Official records
- AccessGUDID record 00607567207844
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Adult ECC Pack
- Generic name
- Cardiopulmonary bypass system blood tubing set
- Model / Ref / Catalog
- BO TOP 28903, 709000093
- Description
- BEQ HMOD 70000 BO VHK 31000 BO RF 32 SAT/CRIT Gas Filter
- Primary DI / UDI-DI
- 00607567207844
- FDA product code
- DWF
- GMDN term
- Cardiopulmonary bypass system blood tubing set
- Device class
- Class II
- Regulation number
- 870.4210
- GUDID distribution status
- Not in Commercial Distribution
- Sterilisation method
- Ethylene Oxide
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