FDA UDI
In Commercial Distribution
🇺🇸 United States
Airo™ CPAP Mask Liners
DI: 30850054813283
·
Model: SMPL-AL-25
·
Athfar 828 Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Airo™ CPAP Mask Liners
- Primary DI
- 30850054813283
- Version / Model
- SMPL-AL-25
- Company Name
- Athfar 828 Inc
- Labeler DUNS
- 126152023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2023-09-28
- Public Version
- 1
- Public Version Date
- 2023-10-06
- Public Version Status
- New
- Public Device Record Key
- efa76386-874f-4ec3-81cc-f10a948092de
Device Description
Sample - Airo™ CPAP Mask Liners - Box of 25 - Large
Device Characteristics
- Single Use
- Yes
- 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
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59049 | General-purpose medical fibre padding | A roll, sheet or preformed shape of synthetic (e.g., polyester, polypropylene) or natural (e.g., cotton) fibre intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850054813282 | GS1 | ||||
| Primary | 30850054813283 | GS1 |
Customer Contacts
- Phone
- (231) 598-9377
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 350 Degrees Fahrenheit