FDA UDI
In Commercial Distribution
🇺🇸 United States
STA® - Quality HBPM/LMWH
DI: 03607450006865
·
Model: 00686
·
DIAGNOSTICA STAGO
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STA® - Quality HBPM/LMWH
- Primary DI
- 03607450006865
- Version / Model
- 00686
- Company Name
- DIAGNOSTICA STAGO
- Labeler DUNS
- 262277122
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 4
- Public Version Date
- 2021-04-23
- Public Version Status
- Update
- Public Device Record Key
- 6e3ca3ee-99a6-408d-8c4e-f57d28f34ae3
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GGN | PLASMA, COAGULATION CONTROL | Hematology | 864.5425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56273 | Heparin anti-Xa IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative monitoring of heparin anticoagulant therapy by determining its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03607450006865 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius