FDA UDI
In Commercial Distribution
🇺🇸 United States
Sunset Portable Suction Machine with AC/DC Power
DI: 00848530102579
·
Model: SU100DPA
·
SUNSET HEALTHCARE SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Sunset Portable Suction Machine with AC/DC Power
- Primary DI
- 00848530102579
- Version / Model
- SU100DPA
- Company Name
- SUNSET HEALTHCARE SOLUTIONS, INC.
- Labeler DUNS
- 141668116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-05
- Public Version
- 1
- Public Version Date
- 2024-03-13
- Public Version Status
- New
- Public Device Record Key
- 52d02887-389e-4a83-a11c-a56f0c79d691
Device Description
Sunset Portable Suction Machine with AC/DC Power, 800cc Canister, Detachable Power Cord, Carry Case & Car Adapter
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
- No
- 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 |
|---|---|---|---|---|
| 60331 | Pneumatic line tester, battery-powered | A portable, battery-powered, general-purpose device intended to measure pneumatic line flow rates and pressures (positive and negative) in order to calibrate or test a medical (e.g., anaesthesia machines, suction devices) or industrial device and is not dedicated to a specific discipline. It typically consists of a hand-held electronic box with appropriate pneumatic line connections, a digital display and might also contain built-in sensors (e.g., thermometer, hygrometer) in order to measure additional properties (e.g., atmospheric pressure, humidity and temperature). It is intended to be used by a professional in a professional setting (e.g., clinical engineering). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10848530102576 | GS1 | 2 | Not in Commercial Distribution | 2024-03-05 | |
| Primary | 00848530102579 | GS1 |
Customer Contacts
- Phone
- 877-578-6738
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102626 | 000 |