Coag-sense 03F73-03
GUDID 00860007370861
Coag-Sense PT/INR Professional 3-Box Promo
COAGUSENSE INC.
Prothrombin time (PT) IVD, kit, clotting, rapid| Primary Device ID | 00860007370861 |
| NIH Device Record Key | 04acf6a1-8444-45a8-98cb-3a469c5daa03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coag-sense |
| Version Model Number | 03F73-03 |
| Catalog Number | 03F73-03 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com | |
| Phone | 1-866-903-0890 |
| support@coagusense.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860007370861 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183255
FDA Product Code
| GJS | Test, Time, Prothrombin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-08 |
| Device Publish Date | 2021-09-30 |
On-Brand Devices [Coag-sense]
| 00861900000343 | Coag-Sense Professional Control Test Strip Kit - 10 Ct |
| 00861900000336 | Coag-Sense Test Strip Kit - 50 Ct |
| 00861900000329 | Coag-Sense PT/INR Patient Self-Test System |
| 00861900000312 | Coag-Sense PT/INR Professional System |
| 00861900000305 | Coag-Sense PT/INR Meter |
| 00860007370878 | Coag-Sense PT/INR Professional 5-Box Promo |
| 00860007370861 | Coag-Sense PT/INR Professional 3-Box Promo |
Trademark Results [Coag-sense]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COAG-SENSE 85513208 4310266 Live/Registered |
Coagusense, Inc. 2012-01-10 |
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