525 DS Kit
- Primary DI
- 00848530086411
- Brand
- 525 DS Kit
- Company
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Model
- OF5004DS
- Catalog number
- OF5004DS
- Device description
- This kit contains: 2 OF5004 Foam Cabinet Filters, 1 OF6011 Extended Life Bacteria Filter w/ Muffler, 1 BF1438 Final Bacteria Filter.
- Published
- 2018-07-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00848530086411 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00848530086411 | 00848530086411 | 848530086411 | 0848530086411 |
GMDN Terms
| Term | Definition |
|---|
| CPAP/BPAP unit ambient air filter, reusable | A non-sterile filter designed to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air prior to inhalation; it is not intended to filter medical gases. It is typically a flat sheet or pad composed of tightly woven materials or foam intended to be installed over the air inlet of the CPAP/BPAP device to remove particulates/impurities; it is not intended to filter microbes. This is a reusable device. |
Regulatory Flags
- DUNS number
- 141668116
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- 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
Other Devices From This Company
sunsethcs.com