FDA UDI
In Commercial Distribution
🇺🇸 United States
ClimateLineAir 11 Oxy
DI: 00619498392322
·
Model: 39232
·
RESMED PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ClimateLineAir 11 Oxy
- Primary DI
- 00619498392322
- Version / Model
- 39232
- Company Name
- RESMED PTY LTD
- Labeler DUNS
- 751149311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-04
- Public Version
- 1
- Public Version Date
- 2025-08-12
- Public Version Status
- New
- Public Device Record Key
- b5533768-b39c-4898-bdfb-91ae49316221
Device Description
CLIMATELINEAIR 11 OXY - AME
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
- Yes
- 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 |
|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37705 | Ventilator breathing circuit, reusable | 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, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. 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. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00619498392322 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -13 – 158 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 74 – 101 KiloPascal