FDA UDI
In Commercial Distribution
🇺🇸 United States
Synermed®
DI: 05060500090647
·
Model: UV380-X
·
INFRARED LABORATORY SYSTEMS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Synermed®
- Primary DI
- 05060500090647
- Version / Model
- UV380-X
- Catalog Number
- UV380-X
- Company Name
- INFRARED LABORATORY SYSTEMS LLC
- Labeler DUNS
- 014210494
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-06-11
- Public Version Status
- Update
- Public Device Record Key
- b527cbe0-28ca-4ca9-9b26-a4ce6632df94
Device Description
CO2 Reagent 1 X 250 mL + 1 X powder vial
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
- 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 |
|---|---|---|---|---|
| KHS | Enzymatic, Carbon-Dioxide | Clinical Chemistry | 862.1160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60774 | Carbon dioxide (CO2) 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 bicarbonate (HCO3-) ions [as a measure of carbon dioxide (CO2) concentration] in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060500090647 | GS1 |
Customer Contacts
- Phone
- 317 896-1565
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 4 Degrees Celsius