Identity
- Trade Name
- POINTE SCIENTIFIC Carbon Dioxide Standard FDA UDI
- Generic Name
- Carbon dioxide (CO2) IVD, calibrator FDA UDI
- Device Name
- Intended for use as an carbon dioxide standard for standardization or calibration of PECP / NADH analog carbon dioxide procedures. FDA UDI
- Model / Reference
- C7504-STD FDA UDI
- Description
- Intended for use as an carbon dioxide standard for standardization or calibration of PECP / NADH analog carbon dioxide procedures. FDA UDI
Identifiers
- Catalog Number
- C7504-STD FDA UDI
- Primary DI / UDI-DI
- 00811727010698 FDA UDI
- 510(k) Number
- K012332 FDA UDI
- FDA Product Code
- KHS FDA UDI
- GMDN Term
- Carbon dioxide (CO2) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1160 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
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
No
FDA UDI
Category: Carbon dioxide (CO2) IVD, calibrator
POINTE SCIENTIFIC Carbon Dioxide Standard by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbon dioxide (CO2) IVD, calibrator.
- Atellica CH CO2 Calibrator — Siemens Healthcare Diagnostics · Class II
- Yumizen C1200 CO2 Cal — Horiba Abx · Class II
- Carbon Dioxide Standard — VERICHEM LABORATORIES, INC. · Class II
- Alinity — Abbott · Class II
- Carbon Dioxide Standard, Level F — VERICHEM LABORATORIES, INC. · Class II
- ARCHITECT — Abbott · Class II
- ABX PENTRA CO2 CAL — Horiba Abx · Class II
- ADVIA® Chemistry CO2 Calibrator/Diluent — Siemens Healthcare Diagnostics · 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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI befae98e-6c2c-4a77-b6ce-961893ff6894 37 fields · synced Jun 8, 2026