Identity
- Trade Name
- 1/2" CORONARY PERFUSION PLUG FDA UDI
- Generic Name
- Stopcock FDA UDI
- Device Name
- 1/2 TUBING TO FIT OVER THE CORONARY PERFUSION OUTLET PORT OF AN OXYGENATOR, TO SECURELY SEAL OFF THE PORT, THUS REDUCING THE POSSIBLITY OF THE PORT BEING INADVERTENTLY OPENED DUTING THE HEMOPERFUSION PROCEEDURE. FDA UDI
- Model / Reference
- 301094-000 FDA UDI
- Description
- 1/2 TUBING TO FIT OVER THE CORONARY PERFUSION OUTLET PORT OF AN OXYGENATOR, TO SECURELY SEAL OFF THE PORT, THUS REDUCING THE POSSIBLITY OF THE PORT BEING INADVERTENTLY OPENED DUTING THE HEMOPERFUSION PROCEEDURE. FDA UDI
Identifiers
- Catalog Number
- 301094-000 FDA UDI
- Primary DI / UDI-DI
- B0663010940000 FDA UDI
- 510(k) Number
- K801399 FDA UDI
- FDA Product Code
- DTL FDA UDI
- GMDN Term
- Stopcock FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4290 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
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
1/2" Coronary Perfusion Plug by Novosci Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K801399 also covers:
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
- Novosci Corp.
Sources (1)
- FDA UDI e20b9fb9-f17b-4635-9a1e-dce17ea17d0b 37 fields · synced Jun 8, 2026