Identity
- Trade Name
- Nellcor FDA UDI
- Generic Name
- Exhaled-gas oesophageal intubation detector FDA UDI
- Device Name
- Adult Colorimetric CO2 Detector FDA UDI
- Model / Reference
- EASYCAP II FDA UDI
- Description
- Adult Colorimetric CO2 Detector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521084032 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Exhaled-gas oesophageal intubation detector 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Exhaled-gas oesophageal intubation detector
Nellcor by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exhaled-gas oesophageal intubation detector.
- Ventlab — Ventlab Corp. · Class II
- Kangaroo — Cardinalhealth · Class II
- Kangaroo — Cardinalhealth · Class II
- Ventlab — Ventlab Corp. · Class II
- Ventlab — Ventlab Corp. · Class II
- Ventlab — Ventlab Corp. · Class II
- Ventlab — Ventlab Corp. · Class II
- Ventlab — Ventlab Corp. · 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
- Covidien LP
Sources (1)
- FDA UDI 08ba102b-fd7c-4503-97a2-d7e57c9595ad 36 fields · synced Jun 1, 2026