Identity
- Trade Name
- Pro-Tech FDA UDI
- Generic Name
- Nasal oxygen cannula, basic FDA UDI
- Device Name
- Pro-Flow Adult Nasal Cannula, Single FDA UDI
- Model / Reference
- PRO-FLOW FDA UDI
- Description
- Pro-Flow Adult Nasal Cannula, Single FDA UDI
Identifiers
- Catalog Number
- P1257 FDA UDI
- Primary DI / UDI-DI
- 00606959032200 FDA UDI
- 510(k) Number
- K982293 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Nasal oxygen cannula, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 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: Nasal oxygen cannula, basic
Pro-Tech 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
K982293 also covers:
- CBL, HIGH LEV OUT, 14 M PH — Respironics, Inc.
- CBL, HIGH LEV OUT, 18 F PH — Respironics, Inc.
- CBL, HIGH LEV OUT, 18 M PH — Respironics, Inc.
- CBL, LOW LEV OUT, 1.5MM CONN — Respironics, Inc.
- Cannula — Respironics, Inc.
- High Level Cable 3.5mm — Respironics, Inc.
- PRO-TECH — Respironics, Inc.
- PTAF — Respironics, Inc.
- PTAF — Respironics, Inc.
- PTAF Lite Kit — Respironics, Inc.
- Pro-Tech — Respironics, Inc.
- Stardust — Respironics, Inc.
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
- Respironics, Inc.
Sources (1)
- FDA UDI 953913ad-4c19-449d-ae06-40eed1352cdb 36 fields · synced Jun 8, 2026