FDA UDI
In Commercial Distribution
🇺🇸 United States
ivWatch Patient Monitor
DI: 00814088020382
·
Model: Model 400
·
IVWATCH, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ivWatch Patient Monitor
- Primary DI
- 00814088020382
- Version / Model
- Model 400
- Catalog Number
- 00814088020382
- Company Name
- IVWATCH, LLC
- Labeler DUNS
- 057028415
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-19
- Public Version
- 3
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- d3f72774-3b9c-4947-94de-a7e076a4c149
Device Description
ivWatch Patient Monitor, Model 400, English, Lease
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PMS | Peripheral Intravenous (Piv) Infiltration Monitor | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62254 | Intravenous access site infiltration/extravasation monitoring system monitor | A portable mains (AC-powered) device intended to be used during intravenous fluid administration to detect and alert healthcare professionals to infiltration/extravasation (leaking of fluid into the surrounding tissues). It includes a display, light source, and a light sensor. Light [visible/near infrared (NIR)] from the monitor is directed to the skin surface near the IV access site, and reflected light from the tissues is directed back to the sensor in the monitor, via a dedicated fibreoptic cable (not included); the monitor is intended to detect changes in reflected light which are processed to indicate fluid leakage. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814088020382 | GS1 |
Customer Contacts
- Phone
- 757-705-2461
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 2.5 | Pound | |
| Depth | 2.63 | Inch | |
| Width | 6.14 | Inch | |
| Length | 8.0 | Inch |