Identity
- Trade Name
- Sarns™ Modular Perfusion System 8000 FDA UDI
- Generic Name
- Cardiopulmonary bypass system air bubble/fluid level detector FDA UDI
- Device Name
- 8000 Perfusion System Safety Monitor Providing Air Bubble and Fluid Level Detection Display. FDA UDI
- Model / Reference
- 16404 FDA UDI
- Description
- 8000 Perfusion System Safety Monitor Providing Air Bubble and Fluid Level Detection Display. FDA UDI
Identifiers
- Catalog Number
- 16404 FDA UDI
- Primary DI / UDI-DI
- 00886799000199 FDA UDI
- 510(k) Number
- K915183 FDA UDI
- FDA Product Code
- DTW FDA UDIKRL FDA UDI
- GMDN Term
- Cardiopulmonary bypass system air bubble/fluid level detector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4340 FDA UDI870.4205 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiopulmonary bypass system air bubble/fluid level detector
Sarns™ Modular Perfusion System 8000 by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiopulmonary bypass system air bubble/fluid level detector.
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Cleared under the same submission
K915183 also covers:
- Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems Corporation
- Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems Corporation
- Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems Corporation
- Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems Corporation
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
- Terumo Cardiovascular Systems Corporation
Sources (1)
- FDA UDI c6171778-86dc-4276-8010-2abcce5562cd 35 fields · synced Jun 9, 2026