Avant Pulse Oximeter System
by Nonin Medical, Inc. 5 variants
Ref 9600-0203, 7326-000, 9600-1701, 9600-0201, 9600-0301, 9700-1501, 9600-1503, 9600-0803, 9700-0101, 9600-0303Model MODEL 9600, 8000AA, PCS-EU, MODEL 9600, PULSE OXIMETER HC, MODEL 9600, 8000SL-3, PCS-US, MODEL 9600, 8000AA, PCS-US, MODEL 9600, 8000AA-2, PCS-US, MODEL 9700, 8000SM-3, PCS-US, MODEL 9600, 8000SM-3, PCS-EU, MODEL 9600, 8000J, PCS-EU, MODEL 9700, 8000AA-3, PCS-US, MODEL 9600, 8000AA-2, PCS-EU
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-00849686097955 | Date12 Dec 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Trade Name
- Avant Pulse Oximeter SystemAvant Pulse Oximeter System with Waveform
- Model / Reference
- MODEL 9600, 8000AA, PCS-EU, 9600-0203, PULSE OXIMETER HC, 7326-000, 8000SL-3, PCS-US, 9600-1701, 9600-0201, 8000AA-2, 9600-0301, MODEL 9700, 8000SM-3, 9700-1501, 9600-1503, 8000J, 9600-0803, 8000AA-3, 9700-0101, 9600-0303
- Primary DI / UDI-DI
- 00849686097955, 00833166001914, 00833166005820, 00849686065510, 00849686065503, 00833166005790, 00849686097771, 00849686097863, 00833166009637, 00849686097931
- Basic UDI-DI
- B-00849686097955, B-00833166001914, B-00833166005820, B-00849686065510, B-00849686065503, B-00833166005790, B-00849686097771, B-00849686097863, B-00833166009637, B-00849686097931
- EMDN Code
- Z1203020408 Pulse oximeters
- Device Class
- Class IIb
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000008228
- Authorised representative
- MPS Medical Product Service GmbH DE-AR-000005009
Other devices from Nonin Medical, Inc.
Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Incorporates Medicinal Product: No