FDA UDI
In Commercial Distribution
🇺🇸 United States
Synermed®
DI: 05060500090005
·
Model: IR-500
·
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
- 05060500090005
- Version / Model
- IR-500
- Catalog Number
- IR-500
- 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
- 6
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- e66d87da-27a0-4af7-b59e-d27ad4a7e7bf
Device Description
Automated Clinical Chemistry Analyzer IVD
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JIQ | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | Clinical Chemistry | 862.1645 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56676 | Multiple clinical chemistry analyser IVD, laboratory | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060500090005 | GS1 |
Customer Contacts
- Phone
- 317 896-1565
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K935662 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius