Identity
- Trade Name
- AIR FLOW,CANNULA SAMPLE PACK EUDAMEDPro-Flow FDA UDI
- Generic Name
- Nasal oxygen cannula, basic FDA UDI
- Device Name
- ProTech Air Flow Sensor EUDAMEDAIR FLOW,CANNULA SAMPLE PACK Cannula sample pack includes two of each of the following part numbers P1294 and P1257. P1294 was issued a UDI number 00606959032248 and P1257 was issued a UDI 00606959032200. FDA UDI
- Model / Reference
- P1258 EUDAMEDAIR FLOW,CANNULA SAMPLE PACK FDA UDI
- Description
- AIR FLOW,CANNULA SAMPLE PACK Cannula sample pack includes two of each of the following part numbers P1294 and P1257. P1294 was issued a UDI number 00606959032248 and P1257 was issued a UDI 00606959032200. FDA UDI
Identifiers
- Catalog Number
- P1258 FDA UDI
- Primary DI / UDI-DI
- 00606959040205 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959040205 EUDAMED
- 510(k) Number
- K053063 FDA UDI
- FDA Product Code
- CCK FDA UDI
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Nasal oxygen cannula, basic FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1400 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Air Flow, Cannula Sample Pack by Respironics, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959040205 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED fd519b51-618b-4465-a347-ce545b3162d0 61 fields · synced Jun 18, 2026
- FDA UDI 917e6a4d-4230-48d7-9888-1b4854aa4cd2 37 fields · synced May 30, 2026