| Primary Device ID | 00850003761183 |
| NIH Device Record Key | 40e1a072-6851-4fc0-ace9-f7c7e9f8eba5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QStat Cartridge |
| Version Model Number | QStat Cartridge KIT (Box of 10) |
| Company DUNS | 193921041 |
| Company Name | HEMOSONICS, LLC |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com | |
| Phone | +1(800)280-5589 |
| support@hemosonics.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850003761183 [Unit of Use] |
| GS1 | 10850003761180 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-08 |
| Device Publish Date | 2024-02-29 |
| 00850003761336 - Qstat Control Level 1 | 2024-03-08 For Use with the QUANTRA® Hemostasis Analyzer |
| 00850003761398 - Qstat Control Level 2 | 2024-03-08 For Use with the QUANTRA® Hemostasis Analyzer |
| 00850003761183 - QStat Cartridge | 2024-03-08For Use with the QUANTRA® Hemostasis Analyzer |
| 00850003761183 - QStat Cartridge | 2024-03-08 For Use with the QUANTRA® Hemostasis Analyzer |
| 00850003761107 - Quantra QPlus System | 2021-02-19 Quantra Desktop Remote Viewer |
| 00850003761213 - Quantra QPlus System | 2021-02-19 QPlus Control Level 1 Kit |
| 00850003761275 - Quantra QPlus System | 2021-02-19 QPlus Control Level 2 Kit |
| 00850003761046 - Quantra QPlus System | 2020-10-06 Quantra Cleaning Cartridge |
| 00850003761039 - Qunatra QPlus System | 2019-05-02 Quantra Hemostasis Analyzer |