FDA UDI
In Commercial Distribution
🇺🇸 United States
AirLife
DI: 10885403287138
·
Model: M1043237
·
Carefusion Finland 320 Oy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AirLife
- Primary DI
- 10885403287138
- Version / Model
- M1043237
- Catalog Number
- M1043237
- Company Name
- Carefusion Finland 320 Oy
- Labeler DUNS
- 367919120
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 3
- Public Version Date
- 2020-09-22
- Public Version Status
- Update
- Public Device Record Key
- 43563f44-e6fb-4e7b-89e4-33ab84634a1d
Device Description
HEPA Filter, Disposable Hydrophobic Pleated Bacterial/Viral Filter with Gas Sampling port
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
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAH | Filter, bacterial, breathing-circuit | Anesthesiology | 868.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 | 20885403287135 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 10885403287138 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]