| Primary Device ID | 00814088020047 |
| NIH Device Record Key | c40d5a40-4b9d-4b6f-9290-c9522411d04b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ivWatch Sensor Cable |
| Version Model Number | Model 400 |
| Company DUNS | 057028415 |
| Company Name | IVWATCH, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 757-705-2461 |
| chuck.egress@ivwatch.com | |
| Phone | 757-705-2461 |
| chuck.egress@ivwatch.com |
| Length | 118.1 Inch |
| Length | 118.1 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814088020047 [Primary] |
| GS1 | 10814088020044 [Package] Package: Box [5 Units] In Commercial Distribution |
| GS1 | 20814088020041 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 30814088020048 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 40814088020045 [Package] Contains: 30814088020048 Package: Case [40 Units] In Commercial Distribution |
| GS1 | 50814088020042 [Package] Contains: 30814088020048 Package: Case [40 Units] In Commercial Distribution |
| PMS | Peripheral Intravenous (Piv) Infiltration Monitor |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-07-25 |
| Device Publish Date | 2016-09-14 |
| 00814088020788 - blox | 2021-11-19 Surgical N95 Respirator |
| 00814088020115 - ivWatch Patient Cable | 2020-07-27 Reusable, Electronic Patient Cable |
| 00814088020122 - ivWatch Extension Module | 2020-07-27 A device accessory for the ivWatch Model 400 that provides support for the ivWatch SmartTouch Sensor |
| 20814088020591 - ivWatch SmartTouch Sensor | 2020-07-27 Disposable, Electronic Sensor |
| 00814088020382 - ivWatch Patient Monitor | 2019-07-25 ivWatch Patient Monitor, Model 400, English, Lease |
| 00814088020009 - ivWatch Patient Monitor | 2019-07-25 A device to continuously monitor peripheral IVs for the early detection of IV infiltration and extravasation events |
| 00814088020016 - ivWatch Sensor Receptacle | 2019-07-25 Single-use, sterile sensor receptacle for the ivWatch Model 400. |
| 00814088020047 - ivWatch Sensor Cable | 2019-07-25Reusable fiber optic sensor cable for the ivWatch Model 400. |
| 00814088020047 - ivWatch Sensor Cable | 2019-07-25 Reusable fiber optic sensor cable for the ivWatch Model 400. |