| Primary Device ID | 00814088020009 |
| NIH Device Record Key | 39e67d5f-33c3-4185-8235-7dbbc5a2fc81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ivWatch Patient Monitor |
| Version Model Number | Model 400 |
| Catalog Number | 00814088020009 |
| 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 | false |
| 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 | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Length | 8 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814088020009 [Primary] |
| 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 |
| 00814088020092 | A device to continuously monitor peripheral IVs for the early detection of IV infiltration and e |
| 00814088020009 | A device to continuously monitor peripheral IVs for the early detection of IV infiltration and e |
| 00814088020382 | ivWatch Patient Monitor, Model 400, English, Lease |