FDA UDI
In Commercial Distribution
🇺🇸 United States
AirLife
DI: 10885403276224
·
Model: AH280
·
Carefusion Corporation
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AirLife
- Primary DI
- 10885403276224
- Version / Model
- AH280
- Catalog Number
- AH280
- Company Name
- Carefusion Corporation
- Labeler DUNS
- 830432451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-17
- Public Version
- 5
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- e7bc267a-6b32-4381-8b8c-924dbfffc96d
Device Description
AirLife Adult Heated Wire Circuit Dual-limb, Dual-heated Circuit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| OGL | Oxygen Administration Kit | Anesthesiology | 868.5655 | 2 |
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 |
| 37706 | Ventilator breathing circuit, single-use | An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403276222 | GS1 | CS | 10 | In Commercial Distribution | |
| Primary | 10885403276224 | GS1 |
Customer Contacts
- Phone
- 800.323.9088
- [email protected]