DeVilbiss
- Primary DI
- 00885304000709
- Brand
- DeVilbiss
- Company
- DEVILBISS HEALTHCARE LLC
- Model
- 9352gs
- Catalog number
- 9352gs
- Device description
- Serenity Mask, Gel - Small
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| BZD | Ventilator, Non-Continuous (Respirator) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00885304000709 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00885304000709 | 00885304000709 | 885304000709 | 0885304000709 |
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. |
Regulatory Flags
- DUNS number
- 962175894
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- 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
- false
- Sterilization required before use
- false
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