Identity
- Trade Name
- Sarns™ Centrifugal Pump Adapter FDA UDI
- Generic Name
- Pin-indexed adaptor, reusable FDA UDI
- Model / Reference
- 824043 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00699753450417 FDA UDI
- 510(k) Number
- K112229 FDA UDI
- FDA Product Code
- KFM FDA UDI
- GMDN Term
- Pin-indexed adaptor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4360 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pin-indexed adaptor, reusable
Sarns™ Centrifugal Pump Adapter by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112229 also covers:
- Sarns™ Centrifugal Pump with X-Coating™ — Terumo Cardiovascular Systems Corporation
- Sarns™ Centrifugal Pump with X-Coating™ — Terumo Cardiovascular Systems Corporation
- Sarns™ Centrifugal Pump without X-Coating™ — Terumo Cardiovascular Systems Corporation
- Sarns™ Centrifugal Pump without X-Coating™ — 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 4d00dfc2-0eb9-456a-bd3f-3063c68e6ad9 33 fields · synced Jun 9, 2026