Coag-sense 03P69-10
GUDID 00861900000343
Coag-Sense Professional Control Test Strip Kit - 10 Ct
COAGUSENSE INC.
Prothrombin time (PT) IVD, kit, clotting, rapid Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical| Primary Device ID | 00861900000343 |
| NIH Device Record Key | 1f37f053-a2d0-4005-b719-d41b869322f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coag-sense |
| Version Model Number | 100250 |
| Catalog Number | 03P69-10 |
| 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 |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861900000343 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093243
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 | 2018-10-24 |
| Device Publish Date | 2018-09-23 |
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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