Identity
- Trade Name
- Sensor FDA UDI
- Generic Name
- Nasal oxygen cannula, basic FDA UDI
- Device Name
- Pro-Flow Multipurpose Nasal Cannula, Pediatric, Regular FDA UDI
- Model / Reference
- PRO-FLOW MULTIPURPOSE NASAL CANNULA, PEDIATRIC, REGULAR FDA UDI
- Description
- Pro-Flow Multipurpose Nasal Cannula, Pediatric, Regular FDA UDI
Identifiers
- Catalog Number
- P1345 FDA UDI
- Primary DI / UDI-DI
- 00606959032309 FDA UDI
- 510(k) Number
- K053063 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Nasal oxygen cannula, basic 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
No
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: Nasal oxygen cannula, basic
Sensor by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal oxygen cannula, basic.
- NASAL CANNULA ADULT, WITH 14FT TUBE — BESMED HEALTH BUSINESS CORP. · Class I
- MedSource Nasal Cannula — MEDSOURCE INTERNATIONAL LLC · Class I
- Ventlab — Ventlab Corp. · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- Fisher and Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
- BF — Allied Medical LLC · Class I
Cleared under the same submission
K053063 also covers:
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
- Respironics, Inc.
Sources (1)
- FDA UDI 15d7ee16-9aad-42dc-bceb-43fc90bb9f45 36 fields · synced Jun 6, 2026