FDA UDI
In Commercial Distribution
🇺🇸 United States
Somnera Airbox Air Filter Pack
DI: 30810045450132
·
Model: 19423
·
FRESCA MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Somnera Airbox Air Filter Pack
- Primary DI
- 30810045450132
- Version / Model
- 19423
- Catalog Number
- 19423
- Company Name
- FRESCA MEDICAL, INC.
- Labeler DUNS
- 068329904
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2021-05-07
- Public Version
- 1
- Public Version Date
- 2021-05-17
- Public Version Status
- New
- Public Device Record Key
- f7222606-8ff8-4e21-a412-11aef54ad82f
Device Description
Air Filter pack for use with Somnera Airbox Flow Generator
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| QBY | Positive Airway Pressure System | Anesthesiology | 868.5273 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63172 | CPAP/BPAP unit ambient air filter, reusable | A non-sterile filter designed to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air prior to inhalation; it is not intended to filter medical gases. It is typically a flat sheet or pad composed of tightly woven materials or foam intended to be installed over the air inlet of the CPAP/BPAP device to remove particulates/impurities; it is not intended to filter microbes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810045450131 | GS1 | ||||
| Primary | 30810045450132 | GS1 |
Customer Contacts
- Phone
- 9495423535
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200698 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity