ivWatch Patient Monitor Model 400
Active
CE MDR CE MDD
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00814088020009 | Date14 Sep 2016 | StatusListed |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- ivWatch Patient Monitor
- Generic Name
- Intravenous access site infiltration/extravasation monitoring system monitor
- Model / Ref / Catalog
- Model 400, 00814088020009
- Primary DI / UDI-DI
- 00814088020009
- FDA Product Code
- PMS
- GMDN Term
- Intravenous access site infiltration/extravasation monitoring system monitor
- Device Class
- Class II
- Regulation Number
- 880.5725
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
- Size
- Weight — 2.5 PoundDepth — 2.63 InchWidth — 6.14 InchLength — 8.0 Inch
Other devices from Ivwatch, LLC
Properties
Other properties (11)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No