FDA UDI
In Commercial Distribution
🇺🇸 United States
Airlife
DI: 10889483596081
·
Model: AL7025
·
AIRLIFE
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Airlife
- Primary DI
- 10889483596081
- Version / Model
- AL7025
- Catalog Number
- AL7025
- Company Name
- AIRLIFE
- Labeler DUNS
- 119058668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-20
- Public Version
- 2
- Public Version Date
- 2025-04-17
- Public Version Status
- Update
- Public Device Record Key
- d09cb356-914f-43c9-a5b1-d4d942bebdf3
Device Description
Airlife™ Modudose™ Sterile Water for Inhalation, USP 5 ml
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 |
|---|---|---|---|---|
| 44643 | Intravenous/irrigation solution storage container, single-use | An empty glass or plastic receptacle intended for the safe storage and easy handling of solutions (e.g., sterile distilled water or saline) that are used during intravenous (IV) and/or irrigation procedures; however, it is neither intended to be connected to an IV administration set nor to irrigation equipment. It is produced in a variety of sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30889483596085 | GS1 | Case | 1000 | In Commercial Distribution | |
| Primary | 10889483596081 | GS1 | ||||
| Previous | 10190752196513 | GS1 | ||||
| Package | 20889483596088 | GS1 | Box | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- (800)433-2797
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 77 Degrees Fahrenheit