| Primary Device ID | 00844735006377 |
| NIH Device Record Key | f85ad5f5-124d-46ad-8ddc-5d8a7379a220 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEM FLOW NOW |
| Version Model Number | 520002040011 |
| Catalog Number | GEM2770-FN |
| Company DUNS | 031284586 |
| Company Name | SYNOVIS MICRO COMPANIES ALLIANCE, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | +1(800)510-3318 |
| smca_information@baxter.com | |
| Phone | +1(800)510-3318 |
| smca_information@baxter.com | |
| Phone | +1(800)510-3318 |
| smca_information@baxter.com | |
| Phone | +1(800)510-3318 |
| smca_information@baxter.com | |
| Phone | +1(800)510-3318 |
| smca_information@baxter.com | |
| Phone | +1(800)510-3318 |
| smca_information@baxter.com | |
| Phone | +1(800)510-3318 |
| smca_information@baxter.com | |
| Phone | +1(800)510-3318 |
| smca_information@baxter.com | |
| Phone | +1(800)510-3318 |
| smca_information@baxter.com | |
| Phone | +1(800)510-3318 |
| smca_information@baxter.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844735006377 [Primary] |
| IYN | System, imaging, pulsed doppler, ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-29 |
| Device Publish Date | 2024-11-21 |
| 00844735006377 - GEM FLOW NOW | 2024-11-29Doppler Blood Flow Monitoring Device |
| 00844735006377 - GEM FLOW NOW | 2024-11-29 Doppler Blood Flow Monitoring Device |
| 00844735006728 - DERMACLOSE | 2024-07-05 DERMACLOSE (66CM) US-APAC |
| 00844735006735 - DERMACLOSE | 2024-07-05 DERMACLOSE (95CM) US-APAC |
| 10844735006237 - GEM BIOVER Microvascular Clamp | 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins. |
| 10844735006244 - GEM BIOVER Microvascular Clamp | 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins |
| 10844735006251 - GEM BIOVER Microvascular Clamp | 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins |
| 10844735006268 - GEM BIOVER Microvascular Clamp | 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins |
| 10844735006275 - GEM BIOVER Microvascular Clamp | 2022-04-27 Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins |