Identity
- Trade Name
- Custom Pack ECC 1/4x3/16w/QPiD+RF32 FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- BEQ-HMOD 30000-USA Pediatric Quadrox iD, Blood Transfer Bag 1000 ml - 2 spike ports, BEQ-RF32 RotaFlow, Blood Microfilter System SQ 40 S, Gas Filter, Pediatric Temp Probe FDA UDI
- Model / Reference
- BEQ-TOP 4709 FDA UDI
- Description
- BEQ-HMOD 30000-USA Pediatric Quadrox iD, Blood Transfer Bag 1000 ml - 2 spike ports, BEQ-RF32 RotaFlow, Blood Microfilter System SQ 40 S, Gas Filter, Pediatric Temp Probe FDA UDI
Identifiers
- Catalog Number
- 701068044R01 FDA UDI
- Primary DI / UDI-DI
- 00607567209862 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Custom Pack ECC 1/4x3/16w/QPiD+RF32 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 a5270959-b82a-40bb-a9db-b980541032a0 37 fields · synced May 30, 2026