Identity
- Trade Name
- Gold Edition Carbon Dioxide Analyzer FDA UDI
- Generic Name
- Carbon dioxide monitor FDA UDI
- Device Name
- CO2 Analyzer FDA UDI
- Model / Reference
- 17515 FDA UDI
- Description
- CO2 Analyzer FDA UDI
Identifiers
- Catalog Number
- 17515 FDA UDI
- Primary DI / UDI-DI
- 00850644007008 FDA UDI
- 510(k) Number
- K973544 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Carbon dioxide monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Carbon dioxide monitor
Gold Edition Carbon Dioxide Analyzer by Vacumed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbon dioxide monitor.
- cap-ONE — Nihon Kohden Corp. · Class I
- CD3A — AEI TECHNOLOGIES INC. · Class II
- cap-ONE — Nihon Kohden Corp. · Class II
- BCI — ICU MEDICAL, INC. · Class II
- cap-ONE — Nihon Kohden Corp. · Class II
- cap-ONE — NIHON KOHDEN AMERICA, INC. · Class II
- cap-ONE — Nihon Kohden Corp. · Class I
- Nonin — Nonin Medical, 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
- Vacumed
Sources (1)
- FDA UDI a191ed13-a191-47cd-b13b-98ca3220a2cd 36 fields · synced Jun 8, 2026