Identity
- Trade Name
- DATA MASTER FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood gas sensor FDA UDI
- Model / Reference
- V38 SAT - 3/8 x 3/8 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033178104715 FDA UDI
- 510(k) Number
- K092463 FDA UDI
- FDA Product Code
- DTQ FDA UDI
- GMDN Term
- Cardiopulmonary bypass system blood gas sensor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4220 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Category: Cardiopulmonary bypass system blood gas sensor
Data Master by Sorin Group Italia Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system blood gas sensor.
- CDI™ H/S Cuvette 3/8 x 3/8 - Japan — Terumo Cardiovascular Systems Corporation · Class II
- CDI™ H/S Cuvette 3/8 x 3/8 with Extension — Terumo Cardiovascular Systems Corporation · Class II
- CDI™ H/S Cuvette 1/2 x 1/2 - Japan — Terumo Cardiovascular Systems Corporation · Class II
- CDI™ H/S Cuvette 1/4 x 1/4 - Japan — Terumo Cardiovascular Systems Corporation · Class II
- CDI™ H/S Cuvette 1/2 x 1/2 with Extension — Terumo Cardiovascular Systems Corporation · Class II
- CDI™ H/S Cuvette 1/4 x 1/4 with Extension — Terumo Cardiovascular Systems Corporation · Class II
- TMC 25 — MEDTRONIC, INC. · Class II
- CDI™ H/S Cuvette 1/2 x 1/2 — Terumo Cardiovascular Systems Corporation · Class II
Cleared under the same submission
K092463 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
- Sorin Group Italia Srl
Sources (1)
- FDA UDI dbaeed7f-eb8e-46e1-a328-ffabe41c3a99 33 fields · synced Jun 1, 2026