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SOMAVAC 100 Sustained Vacuum System

FDA UDI

Class I (US FDA UDI)

by Somavac Medical Solutions, Inc.

Identity

Trade Name
SOMAVAC 100 Sustained Vacuum System FDA UDI
Generic Name
Closed-wound drainage suction pump FDA UDI
Device Name
Portable, battery powered vacuum source with waste containers and accessories. FDA UDI
Model / Reference
10011 FDA UDI
Description
Portable, battery powered vacuum source with waste containers and accessories. FDA UDI

Identifiers

Catalog Number
10011 FDA UDI
Primary DI / UDI-DI
00850004219027 FDA UDI
510(k) Number
K180606 FDA UDI
FDA Product Code
GCY FDA UDI
BTA FDA UDI
GMDN Term
Closed-wound drainage suction pump FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4680 FDA UDI
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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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
MRI Safety
MR Unsafe FDA UDI

Category: Closed-wound drainage suction pump

SOMAVAC 100 Sustained Vacuum System by Somavac Medical Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Closed-wound drainage suction pump.

Cleared under the same submission

K180606 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Somavac Medical Solutions, Inc.

Sources (1)

  • FDA UDI 6039a784-bcd1-49b0-b401-2a8b9ae751e5 35 fields · synced Jun 8, 2026