Identity
- Trade Name
- HF Std Pack with BC 60 Plus FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- BC 60 Plus FDA UDI
- Model / Reference
- T8036 FDA UDI
- Description
- BC 60 Plus FDA UDI
Identifiers
- Catalog Number
- 701066990 FDA UDI
- Primary DI / UDI-DI
- 00607567206489 FDA UDI
- FDA Product Code
- DWE FDA UDI
- GMDN Term
- Cardiopulmonary bypass system blood tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4390 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
HF Std Pack with BC 60 Plus by Datascope Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Datascope Corp.
Sources (1)
- FDA UDI adbcbb02-3fc6-497d-b783-93cdc5bb955b 37 fields · synced May 31, 2026