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Amvex Vacuum Regulator

FDA UDI

Class II (US FDA UDI)

by Ohio Medical LLC

Identity

Trade Name
Amvex Vacuum Regulator FDA UDI
Generic Name
Vacuum suction regulator/regulation set, general-purpose FDA UDI
Device Name
VR-I2 series, VacReg, Int 2Mode 300mmHg, Digital FDA UDI
Model / Reference
I2D FDA UDI
Description
VR-I2 series, VacReg, Int 2Mode 300mmHg, Digital FDA UDI

Identifiers

Primary DI / UDI-DI
00628101501310 FDA UDI
FDA Product Code
KDP 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

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

Amvex 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.

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 225cc18a-9e5c-47d5-bae3-2d2c1a20f798 34 fields · synced May 31, 2026