FDA UDI
In Commercial Distribution
🇺🇸 United States
AirLife™
DI: 10190752148901
·
Model: 4698T
·
VYAIRE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AirLife™
- Primary DI
- 10190752148901
- Version / Model
- 4698T
- Catalog Number
- 4698T
- Company Name
- VYAIRE MEDICAL, INC.
- Labeler DUNS
- 080456871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-22
- Public Version
- 1
- Public Version Date
- 2022-08-30
- Public Version Status
- New
- Public Device Record Key
- ddb6ad5a-1608-4a2a-9e4b-2bfa6e44e33f
Device Description
Tri-Flo™ Suction Cath-N-Glove™ Kit
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
- Yes
- 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 |
|---|---|---|---|---|
| OFO | Airway suction kit | Anesthesiology | 868.6810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34041 | Tracheobronchial suction/insufflation catheter, single-lumen | A sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a single lumen tube for alternating suction and insufflation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50190752148909 | GS1 | CASE | 100 | In Commercial Distribution | |
| Primary | 10190752148901 | GS1 |
Customer Contacts
- Phone
- +1(833)327-3284
- [email protected]