Identity
- Trade Name
- Kit, Sample, ETCO2, 3160 FDA UDI
- Generic Name
- Exhaled-gas sample collector, non-electronic FDA UDI
- Model / Reference
- Kit, Sample, EtCO2, 3160 FDA UDI
Identifiers
- Catalog Number
- 94021 FDA UDI
- Primary DI / UDI-DI
- 00884838045149 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Exhaled-gas sample collector, non-electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Kit, Sample, ETCO2, 3160 by Philips DS North America LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Philips DS North America LLC
Sources (1)
- FDA UDI 53619e51-1a00-43a0-810e-04218b5ae60a 35 fields · synced Jun 8, 2026