FDA UDI
In Commercial Distribution
🇺🇸 United States
AirLife
DI: 10885403276668
·
Model: 205931
·
Carefusion Corporation
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AirLife
- Primary DI
- 10885403276668
- Version / Model
- 205931
- Catalog Number
- 205931
- Company Name
- Carefusion Corporation
- Labeler DUNS
- 830432451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 5
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- da3552c3-fb18-4d6d-8a70-b9e1279b5d52
Device Description
AirLife™ Catheter Mount with gas sampling elbow and HCH/filter
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| 42476 | Breathing circuit catheter mount, single-use | A device designed to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end; it may include an integrated suction port or be provided with a microbial medical gas filter. This is a single-use device. | No | Active |
| 60837 | Microbial medical gas filter, single-use | A screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403276666 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 10885403276668 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]