FDA UDI
In Commercial Distribution
🇺🇸 United States
AirLife™
DI: 10190752145122
·
Model: AH132
·
VYAIRE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AirLife™
- Primary DI
- 10190752145122
- Version / Model
- AH132
- Catalog Number
- AH132
- Company Name
- VYAIRE MEDICAL, INC.
- Labeler DUNS
- 080456871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-17
- Public Version
- 2
- Public Version Date
- 2020-07-23
- Public Version Status
- Update
- Public Device Record Key
- af37dfed-20b6-4f48-8488-c8ba04dbecc5
Device Description
AirLife™ Infant Single Limb Heated Wire Circuit Kit Single-limb, Single-heated, continuous-flow circuit (>4 L/min) Contains AH032 Circuit, AH290 Chamber
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
- Yes
- 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 |
|---|---|---|---|---|
| OFP | Anesthesia breathing circuit kit (adult & pediatric) | Anesthesiology | 868.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60699 | Inspiratory line humidification chamber, single-use | A device intended to be fitted to a heated inspiratory line humidifier (e.g., positive-airway-pressure sleep apnoea treatment unit humidifier, heated inspiratory line humidifier) to contain water for the purpose of humidifying respiratory gases. It is a plastic chamber intended to allow the water to be heated by the attached humidifier and the subsequent vapour to be delivered to the patient through a connected breathing circuit. It may be used in a healthcare setting or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50190752145120 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 10190752145122 | GS1 |
Customer Contacts
- Phone
- +1(833)327-3284
- [email protected]