| Primary Device ID | 00861900000350 |
| NIH Device Record Key | 5aee5983-7171-483a-84bd-453a68b9daa6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coag-Sense PT/INR Meter |
| Version Model Number | 200107 |
| Catalog Number | 03P73-01 |
| Company DUNS | 007943352 |
| Company Name | COAGUSENSE INC. |
| 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 | 1-866-903-0890 |
| techsupport@coagusense.com | |
| Phone | 1-866-903-0890 |
| techsupport@coagusense.com | |
| Phone | 1-866-903-0890 |
| techsupport@coagusense.com | |
| Phone | 1-866-903-0890 |
| techsupport@coagusense.com | |
| Phone | 1-866-903-0890 |
| techsupport@coagusense.com | |
| Phone | 1-866-903-0890 |
| techsupport@coagusense.com | |
| Phone | 1-866-903-0890 |
| techsupport@coagusense.com | |
| Phone | 1-866-903-0890 |
| techsupport@coagusense.com | |
| Phone | 1-866-903-0890 |
| techsupport@coagusense.com | |
| Phone | 1-866-903-0890 |
| techsupport@coagusense.com | |
| Phone | 1-866-903-0890 |
| techsupport@coagusense.com | |
| Phone | 1-866-903-0890 |
| techsupport@coagusense.com |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861900000350 [Primary] |
| GJS | Test, Time, Prothrombin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-11 |
| Device Publish Date | 2019-04-03 |
| 00850040656022 - Assure PT Care PT/INR Monitoring System | 2023-04-14 Assure PT Care PT/INR Monitoring System |
| 00850040656039 - Assure PT Care Test Strip Kit | 2023-04-14 Arkray Assure PT Care Test Strip, 50 Count |
| 00860007370861 - Coag-sense | 2021-10-08 Coag-Sense PT/INR Professional 3-Box Promo |
| 00860007370878 - Coag-sense | 2021-10-08 Coag-Sense PT/INR Professional 5-Box Promo |
| 10861900000395 - Coag-Sense Test Strip Kit, 50 ct. | 2021-09-17 Test Strip Kit, 50 ct. |
| 00861900000350 - Coag-Sense PT/INR Meter | 2019-04-11Coag-Sense PT/INR Meter |
| 00861900000350 - Coag-Sense PT/INR Meter | 2019-04-11 Coag-Sense PT/INR Meter |
| 00861900000374 - Coag-Sense PT/INR Professional System | 2019-04-11 Coag-Sense PT/INR Professional System |
| 00861900000381 - Coag-Sense PT/INR Patient Self-Test System | 2019-04-11 Coag-Sense PT/INR Patient Self-Test System |