| Primary Device ID | 10711234103012 |
| NIH Device Record Key | ab67d142-7e5c-47bb-9588-32fec44d942c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemochron Whole Blood Microcoagulation System |
| Version Model Number | J103 |
| Catalog Number | J103 |
| Company DUNS | 079299318 |
| Company Name | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
| Device Count | 45 |
| 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 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00711234103015 [Unit of Use] |
| GS1 | 10711234103012 [Primary] |
| JPA | System, Multipurpose For In Vitro Coagulation Studies |
| 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 |
| 10711234510070 | Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument (Loaner) |
| 10711234510056 | Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument (Demonstrat |
| 10711234510025 | Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument Refurbished |
| 10711234510018 | Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument |
| 10711234540107 | Temperature Verification Cartridge |
| 10711234540091 | Electronic System Verification - Abnormal |
| 10711234540084 | Electronic System Verification - Normal |
| 10711234540077 | Electronic System Verification Kit |
| 10711234540039 | Report Maker V6.01 |
| 10711234103081 | ACT-Low Range Cuvettes - 45 cuvettes/box. |
| 10711234103043 | Citrate PT Cuvette - 45 test cuvettes/box. |
| 10711234103036 | PT Cuvette - 45 test cuvettes/box. |
| 10711234103029 | Citrate APTT Cuvette - 45 test cuvettes/box. |
| 10711234103012 | APTT Cuvette - 45 test cuvettes/box |