FDA UDI
In Commercial Distribution
🇺🇸 United States
Take-up Tubes, 14 inch, Qty 100
DI: 03661540302336
·
Model: SS-044
·
ELITECHGROUP INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Take-up Tubes, 14 inch, Qty 100
- Primary DI
- 03661540302336
- Version / Model
- SS-044
- Company Name
- ELITECHGROUP INC.
- Labeler DUNS
- 052423787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-19
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 5a7988d6-a9a7-4a85-92e1-bdbc1003dfb8
Device Description
The Take-up tubes are intended to be used with the 3120 SWEAT•CHEK Sweat Conductivity Analyzer for sweat analysis for the laboratory diagnosis of cystic fibrosis. The tubes allow for a sweat specimen as small as 6 to 10 microliters to be measured.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| CGZ | Electrode, Ion-Specific, Chloride | Clinical Chemistry | 862.1170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60268 | Sweat conductivity analyser IVD | A portable, electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative measurement of the electrical conductivity of a sweat specimen, as an indicator of total electrolyte concentration, by measuring the ease at which an electric current passes between two points of a conductor in a flow-through cell maintained at a precisely controlled temperature. Calibration solutions and controls are used to validate these results which are typically used to help diagnose cystic fibrosis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661540302336 | GS1 |
Customer Contacts
- Phone
- 1-800-453-2725
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K863395 | 000 |