HACH - TOP LEVEL ASSY, CM130 - HACH COMPANY

Duns Number:091381780

Device Description: TOP LEVEL ASSY, CM130

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More Product Details

Catalog Number

9638600

Brand Name

HACH

Version/Model Number

9638600

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

K162471

Product Code Details

Product Code

FIP

Product Code Name

Subsystem, Water Purification

Device Record Status

Public Device Record Key

0a22f752-eec1-4861-a6dd-30302559d492

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HACH COMPANY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10