| Primary Device ID | 00814384020406 |
| NIH Device Record Key | e2a3c199-9f7b-46c9-ba22-f6d914b24375 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hands Free Syringe |
| Version Model Number | HFS-PDL |
| Catalog Number | 411983-001 |
| Company DUNS | 189689800 |
| Company Name | CONCERT MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| 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 |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 120 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814384020406 [Primary] |
| FRN | Pump, Infusion |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-01-06 |
| 00814384020413 | 1 Motor Housing unit that injects/aspirates the HFS Sterile Syringe |
| 00814384020406 | 1 Foot pedal unit that controls injection/aspiration of HFS Sterile Syringe. |
| 00814384020383 | Pouch of 1 sterile 20 mL syringe, stored inside a box of 20 |