Identity
- Trade Name
- Comfort Soft Plus FDA UDI
- Generic Name
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
- Device Name
- Comfort Soft Plus ETCo2/O2 Divided Pediatric Cannula FDA UDI
- Model / Reference
- 0916 FDA UDI
- Description
- Comfort Soft Plus ETCo2/O2 Divided Pediatric Cannula FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10889483230312 FDA UDI
- 510(k) Number
- K151421 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Nasal oxygen cannula, carbon-dioxide-sampling 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
Yes
FDA UDI
Category: Nasal oxygen cannula, carbon-dioxide-sampling
Comfort Soft Plus by Salter Labs — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal oxygen cannula, carbon-dioxide-sampling.
- CO2 Sampling Nasal Cannula — WESTMED, INC. · Class II
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- Microstream Advance — ORIDION MEDICAL 1987 LTD. · Class II
- Omnistream — ORIDION MEDICAL 1987 LTD. · Class II
- Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- AirLife™ — Airlife, Inc. · Class II
Cleared under the same submission
K151421 also covers:
- CO2 Sampling Nasal Cannula — SALTER LABS
- CapnuVue — SALTER LABS
- CapnuVue — SALTER LABS
- Comfort Soft Plus — SALTER LABS
- Comfort Soft Plus — SALTER LABS
- Comfort Soft Plus — SALTER LABS
- Comfort Soft Plus — SALTER LABS
- Iradimed — SALTER LABS
- Iradimed Pediatric Capnography Cannula — SALTER LABS
- Mindray Cannula — SALTER LABS
- Philips MR Patient Care LoFlo Cannula Line — SALTER LABS
- Philips MR Patient Care LoFlo Cannula Line — SALTER LABS
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
- Salter Labs
Sources (1)
- FDA UDI 9c491418-773a-454f-90a7-9dcdedfe94e4 34 fields · synced May 30, 2026