FDA UDI
In Commercial Distribution
🇺🇸 United States
AirLife™
DI: 10889483570845
·
Model: 001905A
·
AIRLIFE
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- AirLife™
- Primary DI
- 10889483570845
- Version / Model
- 001905A
- Catalog Number
- 001905A
- Company Name
- AIRLIFE
- Labeler DUNS
- 119058668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-11
- Public Version
- 2
- Public Version Date
- 2025-04-17
- Public Version Status
- Update
- Public Device Record Key
- c37e5bd5-9d09-40e3-9180-37c9e53e062b
Device Description
Pediatric Volumetric Incentive Spirometer
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
- 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 |
|---|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | Anesthesiology | 868.5690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31266 | Incentive spirometer | A hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility and in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30889483570849 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 10889483570845 | GS1 | ||||
| Previous | 10190752117167 | GS1 |
Customer Contacts
- Phone
- (800)433-2797
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K791819 | 000 |