Identity
- Trade Name
- OR Pack -HMO and RF FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- HMO 7100 BO Coated Quadrox i Adult with integral filter BO-VHK 71000 Venous Reservoir Blood Transfer Bag 1000 ml BO-RF 32 RotaFLow BC 140 Plus BMU Cell Ven 1/2 Prebypass filter w/o Vent Posous Media 3/8 x 1/2 Gas Filter FDA UDI
- Model / Reference
- BO-TOP 15200 FDA UDI
- Description
- HMO 7100 BO Coated Quadrox i Adult with integral filter BO-VHK 71000 Venous Reservoir Blood Transfer Bag 1000 ml BO-RF 32 RotaFLow BC 140 Plus BMU Cell Ven 1/2 Prebypass filter w/o Vent Posous Media 3/8 x 1/2 Gas Filter FDA UDI
Identifiers
- Catalog Number
- 701050647 FDA UDI
- Primary DI / UDI-DI
- 00607567204560 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardiopulmonary bypass system blood tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 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
OR Pack -HMO and RF 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 1511f77e-8f85-4c18-87f6-5eb41eb4ff7b 37 fields · synced Jun 8, 2026