FDA UDI
In Commercial Distribution
🇺🇸 United States
Synermed®
DI: 05060500090548
·
Model: IR050-WK
·
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
- 05060500090548
- Version / Model
- IR050-WK
- Catalog Number
- IR050-WK
- 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
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6e921b87-3d13-4c77-af73-786be2af9871
Device Description
Chloride Reagent 4 X 50 mL
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 |
|---|---|---|---|---|
| CHG | Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride | Clinical Chemistry | 862.1170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52879 | Chloride (Cl-) 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 chloride (Cl-) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060500090548 | GS1 |
Customer Contacts
- Phone
- 317 896-1565
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K903103 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius