Identity
- Trade Name
- SP5045 FDA UDI
- Generic Name
- Thermal-dilution cardiac output unit FDA UDI
- Device Name
- Single device, Injectate Housing SP5045 FDA UDI
- Model / Reference
- 680006 FDA UDI
- Description
- Single device, Injectate Housing SP5045 FDA UDI
Identifiers
- Catalog Number
- 680006 FDA UDI
- Primary DI / UDI-DI
- 00886333600069 FDA UDI
- FDA Product Code
- DQO FDA UDI
- GMDN Term
- Thermal-dilution cardiac output unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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
Yes
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
Category: Thermal-dilution cardiac output unit
Sp5045 by Argon Critical Care Systems Singapore Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thermal-dilution cardiac output unit.
- Transonic — Transonic Systems Inc. · Class II
- Transonic — Transonic Systems Inc. · Class II
- Transonic — Transonic Systems Inc. · Class II
- CO-SET+ — Edwards Lifesciences LLC · Class II
- Transonic — Transonic Systems Inc. · Class II
- Transonic — Transonic Systems Inc. · Class II
- Transonic — Transonic Systems Inc. · Class II
- Transonic — Transonic Systems Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Argon Critical Care Systems Singapore Pte. Ltd.
Sources (1)
- FDA UDI 2de1e56c-1ed9-494e-ad18-9253ee9a005c 35 fields · synced May 30, 2026