| Primary Device ID | 10711234101391 |
| NIH Device Record Key | dbca0d0f-342a-4158-8838-704d64e60a65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemochron Whole Blood Coagulation System |
| Version Model Number | HRFTK-ACT |
| Catalog Number | HRFTK-ACT |
| Company DUNS | 079299318 |
| Company Name | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
| Device Count | 95 |
| DM Exempt | true |
| 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 | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com | |
| Phone | 1-800-678-0710 |
| ilsd_ra.na@werfen.com |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00711234101394 [Unit of Use] |
| GS1 | 10711234101391 [Primary] |
| JBP | Activated Whole Blood Clotting Time |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-08-31 |
| Device Publish Date | 2016-09-22 |
| 10711234540060 | Temperature Verification Tube |
| 10711234540053 | Electronic System Verification Tube |
| 10711234540022 | Data Manager V3.0 |
| 10711234520062 | Hemochron Whole Blood Coagulation System - Hemochron Response Instrument (Demonstration) |
| 10711234520055 | Hemochron Whole Blood Coagulation System - Hemochron Response Instrument (Loaner) |
| 10711234520048 | Hemochron Whole Blood Coagulation System - Hemochron Response Instrument Refurbished |
| 10711234520017 | Hemochron Whole Blood Coagulation System - Hemochron Response Instrument |
| 10711234202111 | Kaolin Protamine Dose Assay - 40 tubes/box |
| 10711234202104 | Kaolin Protamine Response Test 40 tubes/box |
| 10711234202098 | Kaolin Protamine Response Test 40 tubes/box |
| 10711234202081 | Kaolin Heparin Response Test 40 tubes/box |
| 10711234202067 | Celite Protamine Response Test 40 tubes/box |
| 10711234202050 | Celite Protamine Response Test 40 tubes/box |
| 10711234202036 | Heparin Response Test 40 tubes/box |
| 10711234102206 | ACT Whole Blood Quality Control 40/box |
| 10711234102183 | RxDx Whole Blood Quality Control Protamine 40/box |
| 10711234102176 | RxDx Whole Blood Quality Control Heparin 40/box |
| 10711234101391 | Kaolin ACT Tubes - 95 tubes/box |
| 10711234101384 | Celite ACT Tubes - 95 tubes/box |
| 10711234101230 | Celite Protamine Dose Assay - 40 tubes/box |
| 10711234101094 | ACT Tubes 95 tubes/box |
| 10711234540114 | Temperature Verification Tube |