Adult Oral/Nasal Pressure Monitoring Cannula with 7’ (2.1 m) tube with filter.
Ref 5005-7-25Model Salter Sleep Diagnostic Cannulas
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0607411TF20010_SleepDx9V 10607411500593 | Date6 May 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Salter Sleep Diagnostic Cannulas, 5005-7-25
- Primary DI / UDI-DI
- 10607411500593
- Basic UDI-DI
- 0607411TF20010_SleepDx9V
- Unit of Use DI
- 00607411500596
- EMDN Code
- Z12100585 Polysomnography instruments - consumables
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000007934
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
From the manufacturer
Manufacturer's product page: Ballard™ Turbo-Cleaning Closed Suction Systems with QWIKCLIP
Other devices from Salter Labs, LLC
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No