FDA UDI
In Commercial Distribution
🇺🇸 United States
HemosIL Calibration Plasma
DI: 08426950087595
·
Model: 00020003700
·
INSTRUMENTATION LABORATORY COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- HemosIL Calibration Plasma
- Primary DI
- 08426950087595
- Version / Model
- 00020003700
- Catalog Number
- 00020003700
- 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
- 2021-07-13
- Public Version Status
- Update
- Public Device Record Key
- e8a7a790-9c81-453a-ad6a-91357380821a
Device Description
HemosIL Calibration Plasma
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 |
|---|---|---|---|---|
| JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55995 | Multiple coagulation factor IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950087595 | GS1 | ||||
| Unit of Use | 18426950087592 | GS1 |
Customer Contacts
- Phone
- 1-800-678-0710
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041905 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Unopened Calibration plasma is stable until the expiration date shown on the vial when stored at 2-8°C