Identity
- Trade Name
- Smart CapnoLine / Microstream FDA UDI
- Generic Name
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
- Device Name
- Made In Israel: Smart Capnoline Guard O2 Long FDA UDI
- Model / Reference
- Smart Capnoline Guardian O2 Long FDA UDI
- Description
- Made In Israel: Smart Capnoline Guard O2 Long FDA UDI
Identifiers
- Catalog Number
- 989803183001 FDA UDI
- Primary DI / UDI-DI
- 20884838071265 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nasal oxygen cannula, carbon-dioxide-sampling
Smart CapnoLine / Microstream by Philips Medical Systems Hsg — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal oxygen cannula, carbon-dioxide-sampling.
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- Gas Sampling Lines — SALTER LABS · Class II
- 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
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 Medical Systems Hsg
Sources (1)
- FDA UDI 382b7d2e-9c90-4574-b9ad-fb236d29ca33 36 fields · synced May 30, 2026