Identity
- Trade Name
- SOMAVAC Drain Connector - Dual Output FDA UDI
- Generic Name
- Closed-wound drain connection tubing set FDA UDI
- Device Name
- Sterile Drain Connector with a single input and two outputs. FDA UDI
- Model / Reference
- 10081 FDA UDI
- Description
- Sterile Drain Connector with a single input and two outputs. FDA UDI
Identifiers
- Catalog Number
- 10081 FDA UDI
- Primary DI / UDI-DI
- 00850004219096 FDA UDI
- 510(k) Number
- K180606 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Closed-wound drain connection tubing set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
Category: Closed-wound drain connection tubing set
SOMAVAC Drain Connector - Dual Output by Somavac Medical Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K180606 also covers:
- SOMAVAC 100 Sustained Vacuum System — SOMAVAC MEDICAL SOLUTIONS, INC.
- SOMAVAC Belt — SOMAVAC MEDICAL SOLUTIONS, INC.
- SOMAVAC Belt Extender — SOMAVAC MEDICAL SOLUTIONS, INC.
- SOMAVAC Drain Connector — SOMAVAC MEDICAL SOLUTIONS, INC.
- SOMAVAC Drain Connector - Dual Input — SOMAVAC MEDICAL SOLUTIONS, INC.
- SOMAVAC Waste Collection Unit — SOMAVAC MEDICAL SOLUTIONS, INC.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Somavac Medical Solutions, Inc.
Sources (1)
- FDA UDI 28f6a8a6-c3d8-436f-8b85-a80d7b8248e5 35 fields · synced May 30, 2026