FDA UDI
In Commercial Distribution
🇺🇸 United States
HemosIL PT-Fibrinogen
DI: 08426950452836
·
Model: 00009756710
·
INSTRUMENTATION LABORATORY COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- HemosIL PT-Fibrinogen
- Primary DI
- 08426950452836
- Version / Model
- 00009756710
- Catalog Number
- 00009756710
- Company Name
- INSTRUMENTATION LABORATORY COMPANY
- Labeler DUNS
- 557223252
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2021-07-14
- Public Version Status
- Update
- Public Device Record Key
- 9401eb44-2d4c-402c-b90e-89cdcca1cf39
Device Description
HemosIL PT-Fibrinogen
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| 55983 | Prothrombin time (PT) IVD, kit, clotting | A collection of reagents and other associated materials intended to be used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR), using a clotting method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950452836 | GS1 | ||||
| Unit of Use | 18426950452833 | GS1 |
Customer Contacts
- Phone
- 1-800-678-0710
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K862301 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Unopened reagent is stable until the expiration date shown on the vial when stored at 2-8°C