FDA UDI
In Commercial Distribution
🇺🇸 United States
Vivatmo pro Oxycap
DI: 04059233000048
·
Model: F09G100152
·
Bosch Healthcare Solutions GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Vivatmo pro Oxycap
- Primary DI
- 04059233000048
- Version / Model
- F09G100152
- Catalog Number
- F09G100152
- Company Name
- Bosch Healthcare Solutions GmbH
- Labeler DUNS
- 341189007
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- 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
- 1087b8a4-7c39-4e16-b139-c60c2c1e34f1
Device Description
Disposable mouthpiece for Vivatmo
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 65819 | Electrochemical breath analyser filter/mouthpiece IVD | A device designed as a breathing mouthpiece and filter intended to be attached to an in vitro diagnostic electrochemical breath analyser to facilitate exhaled air specimen sampling and accurate measurement of target chemical and/or biological markers. It has an integrated reactive filtering material to remove potentially confounding species (e.g., ammonia, methanol) and to chemically prepare the specimen for measurement [e.g., via oxidation]; it may also be designed to remove target particles to provide a control baseline measurement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04059233000048 | GS1 | ||||
| Unit of Use | 04059233000260 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 27 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 60 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 78 – 110 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius