Identity
- Trade Name
- Surge Cardiovascular FDA UDI
- Generic Name
- Cardiopulmonary bypass cannula holder set FDA UDI
- Device Name
- Adult Tourniquet Kit with Snare, 1 red, 1 blue, 7" length, non-sterile FDA UDI
- Model / Reference
- TOU-7904 FDA UDI
- Description
- Adult Tourniquet Kit with Snare, 1 red, 1 blue, 7" length, non-sterile FDA UDI
Identifiers
- Catalog Number
- TOU-7904 FDA UDI
- Primary DI / UDI-DI
- 00817278011306 FDA UDI
- FDA Product Code
- GDJ FDA UDI
- GMDN Term
- Cardiopulmonary bypass cannula holder set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Surge Cardiovascular by Alliant Enterprises, LLC — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Alliant Enterprises, LLC
Sources (1)
- FDA UDI acadef74-fad8-4fd3-879f-fab17d065459 35 fields · synced May 29, 2026