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Gomco

FDA UDI

Class II (US FDA UDI)

by Allied Medical LLC

Identity

Trade Name
GOMCO FDA UDI
Generic Name
Vacuum suction regulator/regulation set, thoracic FDA UDI
Device Name
THORADIC DRAINAGE PUMP FDA UDI
Model / Reference
01-33-6050 FDA UDI
Description
THORADIC DRAINAGE PUMP FDA UDI

Identifiers

Catalog Number
01-33-6050 FDA UDI
Primary DI / UDI-DI
00026072002018 FDA UDI
510(k) Number
K810490 FDA UDI
FDA Product Code
BTA FDA UDI
GMDN Term
Vacuum suction regulator/regulation set, thoracic 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

No

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: Vacuum suction regulator/regulation set, thoracic

Gomco by Allied Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vacuum suction regulator/regulation set, thoracic.

Cleared under the same submission

K810490 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Allied Medical LLC

Sources (1)

  • FDA UDI 7ac6a7f1-3f1e-4549-8c52-3866734798d4 35 fields · synced Jun 8, 2026