Identity
- Trade Name
- SOMAVAC Belt FDA UDI
- Generic Name
- Personal device holder, single-use FDA UDI
- Device Name
- Belt for SOMAVAC Sustained Vacuum System; 25-50in. FDA UDI
- Model / Reference
- 20041 FDA UDI
- Description
- Belt for SOMAVAC Sustained Vacuum System; 25-50in. FDA UDI
Identifiers
- Catalog Number
- 20041 FDA UDI
- Primary DI / UDI-DI
- 00850004219058 FDA UDI
- 510(k) Number
- K180606 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Personal device holder, single-use 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Personal device holder, single-use
SOMAVAC Belt 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 Extender — SOMAVAC MEDICAL SOLUTIONS, INC.
- SOMAVAC Drain Connector — SOMAVAC MEDICAL SOLUTIONS, INC.
- SOMAVAC Drain Connector - Dual Input — SOMAVAC MEDICAL SOLUTIONS, INC.
- SOMAVAC Drain Connector - Dual Output — 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 db2924b3-9d6c-49ef-8baf-844db5ac2c9d 35 fields · synced May 30, 2026