FDA UDI
In Commercial Distribution
🇺🇸 United States
AVEA
DI: 10846446012125
·
Model: 16341-01
·
Carefusion Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AVEA
- Primary DI
- 10846446012125
- Version / Model
- 16341-01
- Company Name
- Carefusion Corporation
- Labeler DUNS
- 830432451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8ee97f05-be2f-40cd-a942-18ca72c28589
Device Description
KIT,AVEA,OPTION,HELIOX,DISS
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
- 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
- No
- 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 |
|---|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37932 | Helium/oxygen quick-connect coupling, female | A female connecting device used to accept a male helium/oxygen connector to connect two devices together to provide a continuous passageway for the delivery of a mixture of 79% helium (He) and 21% oxygen (O2). It has safety features such as a specific mechanical mating pattern, colour coding and a dedicated tube diameter connection to prevent wrong connection and allows a user to rapidly connect and disconnect helium/oxygen dependent devices. It can be attached, e.g., to a regulator or an extension tubing. It can be designed as a diameter-indexed safety system (DISS) connector or a non-interchangeable screw-threaded (NIST) connector. This is not a helium/oxygen terminal unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10846446012125 | GS1 |
Customer Contacts
- Phone
- 800-231-2466
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103211 | 000 |