| Primary Device ID | 10858778006536 |
| NIH Device Record Key | 60aa92cb-a1df-4c02-a6d1-390179012b48 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | P2UVC3.5 |
| Company DUNS | 791238046 |
| Company Name | FOOTPRINT MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 2102262600 |
| info@footprintmed.com |
| Catheter Gauge | 3.5 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858778006539 [Primary] |
| GS1 | 10858778006536 [Package] Contains: 00858778006539 Package: Carton [5 Units] In Commercial Distribution |
| FOS | Catheter, Umbilical Artery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-20 |
| 00858778006850 - N/A | 2024-04-05 Umbilical Probe |
| 10859950007457 - NA | 2022-10-07 Polyurethane Feeding Tube with male Enteral Connector 4.0Fr by 40cm |
| 10859950007464 - NA | 2022-10-07 Polyurethane Feeding Tube with male Enteral Connector 5.0Fr by 40cm |
| 10859950007471 - NA | 2022-10-07 Polyurethane Feeding Tube with male Enteral Connector 6.5Fr by 40cm |
| 10859950007488 - NA | 2022-10-07 Polyurethane Feeding Tube with male Enteral Connector 8.0Fr by 40cm |
| 10859950007495 - NA | 2022-10-07 Polyurethane Feeding Tube with male Enteral Connector 4.0Fr by 60cm |
| 10859950007501 - NA | 2022-10-07 Polyurethane Feeding Tube with male Enteral Connector 5.0Fr by 60cm |
| 10859950007518 - NA | 2022-10-07 Polyurethane Feeding Tube with male Enteral Connector 6.5Fr by 60cm |