FDA UDI
In Commercial Distribution
🇺🇸 United States
ivWatch SmartTouch Sensor
DI: 00814088020597
·
Model: Model 400
·
IVWATCH, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ivWatch SmartTouch Sensor
- Primary DI
- 00814088020597
- Version / Model
- Model 400
- Catalog Number
- 00814088020597
- Company Name
- IVWATCH, LLC
- Labeler DUNS
- 057028415
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-17
- Public Version
- 1
- Public Version Date
- 2020-07-27
- Public Version Status
- New
- Public Device Record Key
- ff0e82d2-6001-40c8-8904-82ebd38da82e
Device Description
Disposable, Electronic Sensor
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 64942 | Intravenous access site infiltration/extravasation monitoring system sensor | A noninvasive, electronic component of an infiltration/extravasation monitoring system intended to emit and receive light to/from the skin surface and transmit electronic signals to the system monitor (not included), for the detection of a fluid leak into surrounding tissues at the site of a peripheral intravenous (IV) infusion. It includes an LED light source, photo detector, with an attached electrical cable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20814088020591 | GS1 | Case | 80 | In Commercial Distribution | |
| Primary | 00814088020597 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192385 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.03 | Pound | |
| Length | 18 | Inch |