HUDSON RCI
- Primary DI
- 34026704717829
- Brand
- HUDSON RCI
- Company
- TELEFLEX INCORPORATED
- Model
- IPN916690
- Catalog number
- RHUD69U
- Device description
- ADDIPAK 0.9% NaCl for Inhalation USP, 15 mL
- Published
- 2020-08-18
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| CAF | Nebulizer (direct patient interface) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 34026704717829 | Package | GS1 | 3 | In Commercial Distribution |
| 14026704717825 | Primary | GS1 | 0 | |
| 44026704717826 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 34026704717829 | 34026704717829 |
| 14026704717825 | 14026704717825 |
| 44026704717826 | 44026704717826 |
GMDN Terms
| Term | Definition |
|---|
| Inhalation therapy saline solution, isotonic | A sterile, isotonic saline solution, consisting only of water and sodium chloride (NaCl), intended to be used to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases, and to help loosen secretions in the respiratory tract of the patient. It is intended to be used with a nebulizer to increase the humidity of respired air through the addition of atomized water to room air or to the gas stream of a breathing circuit. The solution is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the nebulizer. After application, this device cannot be reused. |
Regulatory Flags
- DUNS number
- 002348191
- Device count
- 48
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 46923980105485 | N/A | GaleMed Xiamen Co., Ltd. | CAF | 2026-01-22 |
| 10197344011629 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | CAF | 2026-01-21 |
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