FDA UDI
In Commercial Distribution
🇺🇸 United States
Spare part: Vivatmo pro base station US
DI: 04059233002820
·
Model: F09G100603
·
Bosch Healthcare Solutions GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Spare part: Vivatmo pro base station US
- Primary DI
- 04059233002820
- Version / Model
- F09G100603
- Catalog Number
- F09G100603
- Company Name
- Bosch Healthcare Solutions GmbH
- Labeler DUNS
- 341189007
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-08
- Public Version
- 1
- Public Version Date
- 2024-07-16
- Public Version Status
- New
- Public Device Record Key
- b63bd938-766c-486a-8ef0-d19659b2e4db
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| MXA | System, Test, Breath Nitric Oxide | Clinical Toxicology | 862.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64516 | Electrochemical breath analyser IVD, point-of-care | An electrically-powered point-of-care instrument designed to use electrochemical analysis for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a specimen of air exhaled from a patient. It is used to measure analytes associated with various conditions [e.g., COVID-19 SARS-CoV-2 antigens, hydrogen peroxide (H2O2) as an indicator of inflammation and/or oxidative stress in the airways related to asthma and chronic obstructive pulmonary disorder (COPD)]. It is typically a hand-held or portable instrument, which requires additional consumables such as electrochemical electrode sensors/cartridges and mouthpieces/valves (not included). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 04059233000123 | GS1 | ||||
| Primary | 04059233002820 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 27 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 60 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 78 – 110 KiloPascal
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry