FDA UDI
In Commercial Distribution
🇺🇸 United States
LOANER ALVEOVAC EXTRACTOR
DI: 00850010197937
·
Model: QTLNRAV
·
QUINTRON INSTRUMENT COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LOANER ALVEOVAC EXTRACTOR
- Primary DI
- 00850010197937
- Version / Model
- QTLNRAV
- Catalog Number
- QTLNRAV
- Company Name
- QUINTRON INSTRUMENT COMPANY, INC.
- Labeler DUNS
- 874498744
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-17
- Public Version
- 1
- Public Version Date
- 2023-03-27
- Public Version Status
- New
- Public Device Record Key
- 79c9ec52-93f7-41dc-8ab8-7c313897df31
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
- 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 |
|---|---|---|---|---|
| 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 | 00850010197937 | GS1 |