AMSure® Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL
- Primary DI
- 40704411010334
- Brand
- AMSure® Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL
- Company
- AMSINO INTERNATIONAL, INC.
- Model
- 1
- Catalog number
- AS0552
- Device description
- AMSure® Sterile Water for Inhalation, USP Prefilled Humidifier, 550mL
- Published
- 2019-05-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| CAF | Nebulizer (Direct Patient Interface) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Anesthesiology | 2 |
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 40704411010334 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 40704411010334 | 40704411010334 |
GMDN Terms
| Term | Definition |
|---|
| Inhalation therapy sterile water | A quantity of sterile water (H2O) intended to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases. It is typically used with various types of inhalation therapy devices (e.g., humidifiers, nebulizers, oxygen therapy delivery systems) to increase the humidity of respired air through the addition of vaporized/atomized water to room air or to the gas stream of a breathing circuit. The water contains no additional solutes, is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the inhalation therapy device. After application, it cannot be reused. |
Regulatory Flags
- DUNS number
- 825673239
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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