FDA UDI
In Commercial Distribution
🇺🇸 United States
AirLife™
DI: 10889483631362
·
Model: 37736CE
·
AIRLIFE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- AirLife™
- Primary DI
- 10889483631362
- Version / Model
- 37736CE
- Catalog Number
- 37736CE
- Company Name
- AIRLIFE
- Labeler DUNS
- 119058668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-21
- Public Version
- 3
- Public Version Date
- 2025-04-22
- Public Version Status
- Update
- Public Device Record Key
- 48675057-e1d9-4c02-ace3-892ac161a11a
Device Description
AirLife DuoTherm® Pediatric Single Limb Circuit 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
- Yes
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | Anesthesiology | 868.5270 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60856 | Oxygen administration kit | A collection of devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30889483631366 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 10889483631362 | GS1 |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight