MediSourceNet, Inc - KWV-DT : KwikVac Detecto, Automatic Activation - Medisourcenet, Inc

Duns Number:118269952

Device Description: KWV-DT : KwikVac Detecto, Automatic Activation Device / 1 each

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More Product Details

Catalog Number

-

Brand Name

MediSourceNet, Inc

Version/Model Number

KWV-DT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

K192035

Product Code Details

Product Code

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Device Record Status

Public Device Record Key

67960933-ada6-4504-97c4-b77f796841d5

Public Version Date

September 07, 2021

Public Version Number

1

DI Record Publish Date

August 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDISOURCENET, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13