FDA UDI
In Commercial Distribution
🇺🇸 United States
Coag-Sense PT/INR Meter
DI: 00861900000350
·
Model: 200107
·
COAGUSENSE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Coag-Sense PT/INR Meter
- Primary DI
- 00861900000350
- Version / Model
- 200107
- Catalog Number
- 03P73-01
- Company Name
- COAGUSENSE INC.
- Labeler DUNS
- 007943352
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-03
- Public Version
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 5aee5983-7171-483a-84bd-453a68b9daa6
Device Description
Coag-Sense PT/INR Meter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GJS | Test, Time, Prothrombin | Hematology | 864.7750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30591 | Prothrombin time (PT) IVD, kit, rapid clotting, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative determination of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), within a short period relative to standard laboratory testing procedures using a clotting method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00861900000350 | GS1 |
Customer Contacts
- Phone
- 1-866-903-0890
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 35 – 72 Degrees Fahrenheit