FDA UDI
In Commercial Distribution
🇺🇸 United States
AlveoVac Exraction System-USA 24VDC
DI: 00850010197500
·
Model: QT05200-M
·
QUINTRON INSTRUMENT COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AlveoVac Exraction System-USA 24VDC
- Primary DI
- 00850010197500
- Version / Model
- QT05200-M
- Catalog Number
- QT05200-M
- Company Name
- QUINTRON INSTRUMENT COMPANY, INC.
- Labeler DUNS
- 874498744
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-15
- Public Version
- 1
- Public Version Date
- 2023-03-23
- Public Version Status
- New
- Public Device Record Key
- c082b329-6a70-4d5c-bb39-5828bf65c9fa
Device Description
A stand-alone accessory which extracts breath samples from approved QuinTron breath collection devices and injects the sample into the BreathTracker SC or H2+ breath analyzer. Approved QuinTron collection devices include our following products: 10ml AlveoVac glass vials, sample holding bags, and QuinTron syringes.
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| NRH | System, Breath Measurement | Clinical Chemistry | 862.1820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43898 | Laboratory instrument/analyser pump IVD | An electromechanical component of a laboratory instrument/analyser used for in vitro diagnostic procedures [e.g., high performance liquid chromatograph (HPLC), coagulation analyser] designed to produce positive and negative (vacuum) pressure during analyser/instrument operation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850010197500 | GS1 |