Identity
- Trade Name
- LA Children's ECC Pack no Bladder FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- BEQ-HMOD 30000-USA Pediatric Quadrox iD Blood Microfilter System SQ 40 S Prebypass filter w/o Vent Porous Media 3/8x3/8 Pediatric Temp Probe FDA UDI
- Model / Reference
- BEQ-TOP 49103 FDA UDI
- Description
- BEQ-HMOD 30000-USA Pediatric Quadrox iD Blood Microfilter System SQ 40 S Prebypass filter w/o Vent Porous Media 3/8x3/8 Pediatric Temp Probe FDA UDI
Identifiers
- Catalog Number
- 709000058 FDA UDI
- Primary DI / UDI-DI
- 00607567208230 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
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
LA Children's ECC Pack no Bladder 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 28e5c55d-e78b-431d-bb56-ae66ad18a546 37 fields · synced May 30, 2026