FDA UDI
In Commercial Distribution
🇺🇸 United States
Hemochron Whole Blood Coagulation System
DI: 10711234101391
·
Model: HRFTK-ACT
·
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
95
Basic Information
- Brand Name
- Hemochron Whole Blood Coagulation System
- Primary DI
- 10711234101391
- Version / Model
- HRFTK-ACT
- Catalog Number
- HRFTK-ACT
- Company Name
- ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- Labeler DUNS
- 079299318
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 95
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 5
- Public Version Date
- 2022-08-31
- Public Version Status
- Update
- Public Device Record Key
- dbca0d0f-342a-4158-8838-704d64e60a65
Device Description
Kaolin ACT Tubes - 95 tubes/box
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
- Yes
- 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 |
|---|---|---|---|---|
| JBP | Activated Whole Blood Clotting Time | Hematology | 864.7140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55994 | Activated clotting time (ACT) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the activated clotting time (ACT) of a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10711234101391 | GS1 | ||||
| Unit of Use | 00711234101394 | GS1 |
Customer Contacts
- Phone
- 1-800-678-0710
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K913861 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius