Klein Touch Pump - Klein Touch Pump - HK SURGICAL INC.

Duns Number:106885259

Device Description: Klein Touch Pump

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More Product Details

Catalog Number

KTP

Brand Name

Klein Touch Pump

Version/Model Number

KTP

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

K123822,K123822

Product Code Details

Product Code

FRN

Product Code Name

Pump, Infusion

Device Record Status

Public Device Record Key

40f89374-aa59-43bb-994c-bfe1bf7ccc32

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

June 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HK SURGICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 77
2 A medical device with a moderate to high risk that requires special controls. 12