FDA UDI
In Commercial Distribution
🇺🇸 United States
CPAP Cleaner
DI: 00848530087067
·
Model: CAP1003SNS
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- CPAP Cleaner
- Primary DI
- 00848530087067
- Version / Model
- CAP1003SNS
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-27
- Public Version
- 1
- Public Version Date
- 2025-09-04
- Public Version Status
- New
- Public Device Record Key
- f631dcec-4530-44b2-852e-d7ae42cfe2fd
Device Description
Sunset CPAP Mask Cleaning Wipes -Bulk- 12/case
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MEC | Disinfector, Medical Devices | General Hospital | 880.6992 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58077 | Medical device cleaning/disinfection wipe | A moist, pre-treated fabric intended to be used to wipe the surface of medical devices and equipment to clean and/or destroy harmful microorganisms or inhibit their activity. The fabric is impregnated with a solution that may include a detergent(s) for cleaning surfaces and/or a disinfectant agent(s) or a precursor compound that forms a disinfectant agent when activated (e.g., by a separate solution). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848530087067 | GS1 |
Customer Contacts
- Phone
- 8775786738
- [email protected]