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Vacuum Regulator

FDA UDI

Class II (US FDA UDI)

by Precision Medical, Inc.

Identity

Trade Name
Vacuum Regulator FDA UDI
Generic Name
Vacuum suction regulator/regulation set, general-purpose FDA UDI
Device Name
PM3400 Series, Vac Reg, Intermittent, 150MMHG w/Vac Trap FDA UDI
Model / Reference
PM3400 series w/ Vac Trap FDA UDI
Description
PM3400 Series, Vac Reg, Intermittent, 150MMHG w/Vac Trap FDA UDI

Identifiers

Primary DI / UDI-DI
00850027043357 FDA UDI
510(k) Number
K944479 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

Yes

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

Vacuum Regulator by Precision Medical, Inc. — 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

K944479 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Precision Medical, Inc.

Sources (1)

  • FDA UDI f4d615cf-11a1-4e0e-859a-a8193e82e25f 35 fields · synced May 30, 2026