FDA UDI
In Commercial Distribution
🇺🇸 United States
Airlife
DI: 10889483598641
·
Model: CN0010
·
AIRLIFE
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Airlife
- Primary DI
- 10889483598641
- Version / Model
- CN0010
- Catalog Number
- CN0010
- Company Name
- AIRLIFE
- Labeler DUNS
- 119058668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-12
- Public Version
- 3
- Public Version Date
- 2026-04-20
- Public Version Status
- Update
- Public Device Record Key
- 1062a1d4-0aa7-4c45-9081-03b8035f3f21
Device Description
WATER STERILE FOR INHALATION 1000mL
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | 868.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44706 | Inhalation therapy sterile water | A quantity of sterile water (H2O) intended to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases. It is typically used with various types of inhalation therapy devices (e.g., humidifiers, nebulizers, oxygen therapy delivery systems) to increase the humidity of respired air through the addition of vaporized/atomized water to room air or to the gas stream of a breathing circuit. The water contains no additional solutes, is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the inhalation therapy device. After application, it cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30889483598645 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 10889483598641 | GS1 | ||||
| Previous | 10190752141773 | GS1 |
Customer Contacts
- Phone
- +1(800)433-2797
- [email protected]