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Surgical Free Flow Vacuum Regulator

FDA UDI

Class II (US FDA UDI)

by Ohio Medical LLC

Identity

Trade Name
Surgical Free Flow Vacuum Regulator FDA UDI
Generic Name
Vacuum suction regulator/regulation set, general-purpose FDA UDI
Device Name
Vacuum Regulator, Surgical Free Flow, 200mmHg Analog FDA UDI
Model / Reference
SCSA FDA UDI
Description
Vacuum Regulator, Surgical Free Flow, 200mmHg Analog FDA UDI

Identifiers

Primary DI / UDI-DI
00628101609245 FDA UDI
510(k) Number
K861261 FDA UDI
FDA Product Code
GCX FDA UDI
GMDN Term
Vacuum suction regulator/regulation set, general-purpose FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6740 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vacuum suction regulator/regulation set, general-purpose

Surgical Free Flow Vacuum Regulator by Ohio Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vacuum suction regulator/regulation set, general-purpose.

Cleared under the same submission

K861261 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ohio Medical LLC

Sources (1)

  • FDA UDI ee5023bc-7d39-4b7e-b8af-4dff8a3c93ba 35 fields · synced May 31, 2026