Identity
- Trade Name
- CDI™ Blood Parameter Monitoring System 500 FDA UDI
- Generic Name
- Extracorporeal blood gas/pH monitor FDA UDI
- Device Name
- Monitor with two blood parameter modules. FDA UDI
- Model / Reference
- 500AV FDA UDI
- Description
- Monitor with two blood parameter modules. FDA UDI
Identifiers
- Catalog Number
- 500AV FDA UDI
- Primary DI / UDI-DI
- 00886799001639 FDA UDI
- 510(k) Number
- K133658 FDA UDI
- FDA Product Code
- DRY FDA UDI
- GMDN Term
- Extracorporeal blood gas/pH monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4330 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: Extracorporeal blood gas/pH monitor
CDI™ Blood Parameter Monitoring System 500 by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K133658 also covers:
- CDI™ Blood Parameter Monitoring System 500 — Terumo Cardiovascular Systems Corporation
- CDI™ Blood Parameter Monitoring System 500 — Terumo Cardiovascular Systems Corporation
- CDI™ Blood Parameter Monitoring System 500 — Terumo Cardiovascular Systems Corporation
- CDI™ Blood Parameter Monitoring System 500 — Terumo Cardiovascular Systems Corporation
- CDI™ Blood Parameter Monitoring System 500 — Terumo Cardiovascular Systems Corporation
- CDI™ Blood Parameter Monitoring System 500 — Terumo Cardiovascular Systems Corporation
- CDI™ Blood Parameter Monitoring System 500 — Terumo Cardiovascular Systems Corporation
- CDI™ Blood Parameter Monitoring System 500 — Terumo Cardiovascular Systems Corporation
- CDI™ H/S Cuvette 1/2 x 1/2 — Terumo Cardiovascular Systems Corporation
- CDI™ H/S Cuvette 1/2 x 1/2 - Japan — Terumo Cardiovascular Systems Corporation
- CDI™ H/S Cuvette 1/2 x 1/2 with Extension — Terumo Cardiovascular Systems Corporation
- CDI™ H/S Cuvette 1/4 x 1/4 — 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 c4693b9a-d7bd-48cd-b574-aa6bce650742 35 fields · synced Jun 9, 2026