Identity
- Trade Name
- Sunset Portable Suction Machine with AC/DC Power FDA UDI
- Generic Name
- Pneumatic line tester, battery-powered FDA UDI
- Device Name
- Sunset Portable Suction Machine with AC/DC Power, 800cc Canister, Detachable Power Cord, Carry Case & Car Adapter FDA UDI
- Model / Reference
- SU100DPA FDA UDI
- Description
- Sunset Portable Suction Machine with AC/DC Power, 800cc Canister, Detachable Power Cord, Carry Case & Car Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530102579 FDA UDI
- 510(k) Number
- K102626 FDA UDI
- FDA Product Code
- JCX FDA UDI
- GMDN Term
- Pneumatic line tester, battery-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pneumatic line tester, battery-powered
Sunset Portable Suction Machine with AC/DC Power by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumatic line tester, battery-powered.
Cleared under the same submission
K102626 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 52d02887-389e-4a83-a11c-a56f0c79d691 35 fields · synced Jun 8, 2026