AirLife
- Primary DI
- 10885403296260
- Brand
- AirLife
- Company
- Carefusion Corporation
- Model
- 9000C5
- Catalog number
- 9000C5
- Device description
- AirLife CPAP Mask
- Published
- 2016-08-29
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | Anesthesiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 50885403296268 | Package | GS1 | 10 | Not in Commercial Distribution |
| 10885403296260 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 50885403296268 | 50885403296268 |
| 10885403296260 | 10885403296260 |
GMDN Terms
| Term | Definition |
|---|
| CPAP/BPAP nasal mask, single-use | A non-sterile, flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Contacts
| Phone | Email |
|---|
| 800.323.9088 | gmb-MedSpec-CustService@carefusion.com |
Regulatory Flags
- DUNS number
- 830432451
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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