Du-O-Vac - Emergency Venturi Suction Device - W. T. FARLEY, INC.

Duns Number:063805113

Device Description: Emergency Venturi Suction Device

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More Product Details

Catalog Number

-

Brand Name

Du-O-Vac

Version/Model Number

MRI-DV-520A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K781988

Product Code Details

Product Code

GCX

Product Code Name

APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Device Record Status

Public Device Record Key

f927f390-b857-47c5-b043-372f09293a27

Public Version Date

August 23, 2018

Public Version Number

4

DI Record Publish Date

June 14, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"W. T. FARLEY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 91