FDA UDI
In Commercial Distribution
🇺🇸 United States
BreathPrep Desiccant
DI: 00850010197258
·
Model: QT01161-C
·
QUINTRON INSTRUMENT COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BreathPrep Desiccant
- Primary DI
- 00850010197258
- Version / Model
- QT01161-C
- Catalog Number
- QT01161-C
- Company Name
- QUINTRON INSTRUMENT COMPANY, INC.
- Labeler DUNS
- 874498744
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-20
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 09e473cb-4410-4b3e-85f0-cad68030562b
Device Description
Component of the BreathTracker medical device.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| NRH | System, Breath Measurement | Clinical Chemistry | 862.1820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57843 | Gas chromatography analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. Volatile components are separated in a gaseous mixture based on their partitioning differences between mobile and stationary phases as they pass through a column. As the substances exit the column they are detected and identified electronically or spectrometrically, based on their structure. The analyser is typically used for the identification of complex substances such as drugs and hormones. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850010197258 | GS1 |