Identity
- Trade Name
- Portable Suction Machine FDA UDI
- Generic Name
- General-purpose suction system, line-powered FDA UDI
- Device Name
- Portable Suction Machine FDA UDI
- Model / Reference
- SU100DC FDA UDI
- Description
- Portable Suction Machine FDA UDI
Identifiers
- Catalog Number
- SU100DC FDA UDI
- Primary DI / UDI-DI
- 00848530088965 FDA UDI
- 510(k) Number
- K102626 FDA UDI
- FDA Product Code
- JCX FDA UDI
- GMDN Term
- General-purpose suction system, line-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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose suction system, line-powered
Portable Suction Machine by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose suction system, line-powered.
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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 f53d1c04-5f6d-4ec5-9606-2eabf068db79 36 fields · synced Jun 1, 2026