FDA UDI
In Commercial Distribution
🇺🇸 United States
Power and Accessories
DI: 00848530091293
·
Model: SU100DC-PA
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Power and Accessories
- Primary DI
- 00848530091293
- Version / Model
- SU100DC-PA
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-08-08
- Public Version
- 1
- Public Version Date
- 2024-08-16
- Public Version Status
- New
- Public Device Record Key
- 108d65c9-12c3-4c4e-8d01-e91b745ee787
Device Description
Portable Suction Machine DC Mobile Power Adapter
Device Characteristics
- Single Use
- No
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63643 | Emergency airway clearance suction pump, electric | An electrically-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure for emergency aspiration of fluids, secretions, or other unwanted materials from the airway of a patient. It is typically used during patient transport or for emergency situations (e.g., placed on a crash cart); it is not intended for surgical use. It may include collection containers, microbial filter, valve, or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10848530091290 | GS1 | ||||
| Primary | 00848530091293 | GS1 |
Customer Contacts
- Phone
- 8775786738
- [email protected]