← Back to catalogue
Cable, Low Level Output, 3/32" (2.381 mm) Male Phone Connector
EUDAMEDFDA UDIClass I (EU MDR)
Ref P1077
Identity
- Trade Name
- Cable, Low Level Output, 3/32" (2.381 mm) Male Phone Connector EUDAMEDCBL, LOW LEV OUT,332 M PH FDA UDI
- Generic Name
- Nasal oxygen cannula, basic FDA UDI
- Device Name
- Pro-Tech Accessories EUDAMEDCBL, LOW LEV OUT,332 M PH FDA UDI
- Model / Reference
- P1077 EUDAMEDCBL FDA UDI
- Description
- CBL, LOW LEV OUT,332 M PH FDA UDI
Identifiers
- Catalog Number
- P1077 FDA UDI
- Primary DI / UDI-DI
- 00606959009929 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959009929 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cable, Low Level Output, 3/32" (2.381 mm) Male Phone Connector by Respironics, 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-00606959009929 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED a254e4b0-6211-4283-b270-6fd72ce60729 61 fields · synced Jul 10, 2026
- FDA UDI 6b968d06-e3bb-4564-b024-c89a79209c19 37 fields · synced May 30, 2026
- EUDAMED f59565c8-85f8-46b5-a7d4-724b212681f7 61 fields · synced Jul 10, 2026