FDA UDI
In Commercial Distribution
🇺🇸 United States
AirLife™
DI: 10889483270585
·
Model: 0397
·
SUNMED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- AirLife™
- Primary DI
- 10889483270585
- Version / Model
- 0397
- Catalog Number
- 0397
- Company Name
- SUNMED, LLC
- Labeler DUNS
- 069009268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-19
- Public Version
- 1
- Public Version Date
- 2025-12-29
- Public Version Status
- New
- Public Device Record Key
- 30d37b3d-f807-4809-a5e7-86ed600aef91
Device Description
AirLife™ Aerosol Drug Delivery System, Kit Contains: 1- Reusable VixOne™ Super Spike™ Mask, 7' Tubing, Pedi-Neb™, 1 - Nebulizer Compressor
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | 868.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62042 | Nebulizing system delivery set, reusable | A collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20889483270582 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 10889483270585 | GS1 | ||||
| Previous | 00709078004865 | GS1 |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K800562 | 000 |