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Sentri, Paediatric, Nasal Cannula With Curved Prongs, Co2 Monitoring Line
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SENTRI, PAEDIATRIC, NASAL CANNULA WITH CURVED PRONGS, CO2 MONITORING LINE FDA UDI
- Generic Name
- Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
- Device Name
- SENTRI, PAEDIATRIC, NASAL CANNULA WITH CURVED PRONGS, CO2 MONITORING LINE FOR M/S CAPNOGRAPHY, FILTER AND TUBE, 2.1M FDA UDI
- Model / Reference
- 1144015 FDA UDI
- Description
- SENTRI, PAEDIATRIC, NASAL CANNULA WITH CURVED PRONGS, CO2 MONITORING LINE FOR M/S CAPNOGRAPHY, FILTER AND TUBE, 2.1M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267159789 FDA UDI
- 510(k) Number
- K122075 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
Yes
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: Nasal oxygen cannula, carbon-dioxide-sampling
Sentri, Paediatric, Nasal Cannula With Curved Prongs, Co2 Monitoring Line by Intersurgical Incorporated — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Nasal oxygen cannula, carbon-dioxide-sampling.
- CO2 Sampling Nasal Cannula — WESTMED, INC. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Dispo-Med CO2 Sampling Line, MLL, W/Filter — DISPO-MED (MALAYSIA) SDN. BHD. · Class II
- 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
Cleared under the same submission
K122075 also covers:
- GAS MONITORING LINE 1.2MM ID, F LUER LOCK/M LUER LOCK, 1.8M — Intersurgical Incorporated
- GAS MONITORING LINE, 1.2MM ID, MALE/MALE LUER LOCK, 3M — Intersurgical Incorporated
- MONITORING LINE 1.8M, MALE - MALE LUER LOCK CONNECTORS — Intersurgical Incorporated
- PVC MONITORING LINE WITH MALE/MALE LUER LOCK CONNECTORS 3.0M — Intersurgical Incorporated
- SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH CO2 MONITORING LINE — Intersurgical Incorporated
- SENTRI INTERSURGICAL ECOLITE, ADULT, MASK WITH CO2 MONITORING LINE, FILTER AND TUBE — Intersurgical Incorporated
- SENTRI, ADULT, NASAL CANNULA WITH CURVED PRONGS, CO2 MONITORING LINE — Intersurgical Incorporated
- SENTRI, INFANT, NASAL CANNULA WITH CURVED PRONGS, CO2 MONITORING LINE — Intersurgical Incorporated
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
- Intersurgical Incorporated
Sources (1)
- FDA UDI cda7ff9a-43a5-4f2c-9940-0809697aafe6 35 fields · synced May 31, 2026