FDA UDI
In Commercial Distribution
🇺🇸 United States
AirLife
DI: 10885403185731
·
Model: 2K8086
·
Carefusion Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AirLife
- Primary DI
- 10885403185731
- Version / Model
- 2K8086
- Catalog Number
- 2K8086
- 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
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 17adeb86-a570-4ae0-8c11-fdd19b824ad0
Device Description
Airlife™ Small AirLife SeeBreath CO2 Detector
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
- 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 |
|---|---|---|---|---|
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46822 | Carbon dioxide sensor/cable | An assembly of electrical wires with a detector (typically infrared spectroscopic) at the distal end designed to connect a carbon dioxide (CO2) cuvette, or other form of translucent window placed in an anaesthetic or ventilatory breathing circuit, with a CO2 patient monitor, for the transmission of electrical signals to measure the CO2 concentration in gases expired by the patient. The proximal end of the device typically has a multi-pinned plug for insertion into the patient monitor. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403185739 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 10885403185731 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 30 Degrees Celsius