| Primary Device ID | 20812747018538 |
| NIH Device Record Key | a6aaf991-95da-4bae-8f41-7e04ce6ffe14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Global Hemostasis - HN |
| Version Model Number | 07-604-US |
| Company DUNS | 057827420 |
| Company Name | HAEMONETICS CORPORATION |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com | |
| Phone | +1(800)-537-2802 |
| pirdesk@Haemonetics.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10812747018531 [Primary] |
| GS1 | 20812747018538 [Package] Contains: 10812747018531 Package: [10 Units] In Commercial Distribution |
| JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-18 |
| Device Publish Date | 2024-04-10 |
| 00812747019807 - Haemonetics® NexSys PCS® System | 2024-10-18 Persona™ Plasma Pooling Bottles |
| 30812747019273 - Haemonetics® PCS®2 & NexSys PCS® Systems | 2024-07-29 PLS HARNESS SET |
| 30812747019341 - Haemonetics® PCS®2 & NexSys PCS® Systems | 2024-07-29 PLS HARNESS SET |
| 30812747019730 - Haemonetics® NexSys PCS® System | 2024-07-25 0625Q-00 Plasma Bowl |
| 20812747018538 - Global Hemostasis - HN | 2024-04-18CITRATED: K, KH, RTH, FFH |
| 20812747018538 - Global Hemostasis - HN | 2024-04-18 CITRATED: K, KH, RTH, FFH |
| 30812747013516 - MCS+ (LN8150) RBC APHERESIS | 2023-10-19 2 UNIT RED CELL SET W/RC2H FIL |
| 30812747015008 - HAEMONETICS ACP 215 SYSTEM | 2023-10-19 RBC GLYCEROLIZATION SET |
| 30812747015015 - HAEMONETICS ACP 215 SYSTEM | 2023-10-19 RBC DE-GLYCEROL./CELL WASH SET |