Cook - Charger For Blood Flow Monitor - DP-M350 - - Cook Vandergrift Inc.

Duns Number:056867526

Device Description: Charger For Blood Flow Monitor - DP-M350 - Non-Sterile

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More Product Details

Catalog Number

DP-M350-CHG1

Brand Name

Cook

Version/Model Number

G55458

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

JOP

Product Code Name

TRANSDUCER, ULTRASONIC

Device Record Status

Public Device Record Key

4f79993b-070e-45db-b4cb-adf9c9d722dc

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COOK VANDERGRIFT INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 48