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Cable, High Level Output, 3/32 (2.381 mm) Male Phone connector
EUDAMEDFDA UDIClass I (EU MDR)
Ref P1080Model Pro-Tech Sensors Wire Sets and Accessories
Identity
- Trade Name
- Cable, High Level Output, 3/32 (2.381 mm) Male Phone connector EUDAMEDCBL,PTAF HIGH LEV OUT,332 M PH FDA UDI
- Generic Name
- Nasal oxygen cannula, basic FDA UDI
- Device Name
- CBL,PTAF HIGH LEV OUT,332 M PH FDA UDI
- Model / Reference
- Pro-Tech Sensors Wire Sets and Accessories EUDAMEDP1080 EUDAMEDCBL FDA UDI
- Description
- CBL,PTAF HIGH LEV OUT,332 M PH FDA UDI
Identifiers
- Catalog Number
- P1080 FDA UDI
- Primary DI / UDI-DI
- 00606959009875 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959009875 EUDAMED
- 510(k) Number
- K982293 FDA UDI
- FDA Product Code
- MNR 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
- 868.2375 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cable, High Level Output, 3/32 (2.381 mm) Male Phone connector by Pro-Tech Services, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00606959009875 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pro-Tech Services, Inc.
- EUDAMED SRN
- US-MF-000002300
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED 14b0f9e9-f9e5-4e71-89bc-7fb2c74998fd 61 fields · synced Jul 27, 2026
- FDA UDI 2079caa2-7819-48a8-91b1-636b5b40f782 37 fields · synced May 24, 2026
- EUDAMED 4d5c2ff1-5409-4e2d-ba30-9fb27ffb08e8 61 fields · synced Jul 27, 2026