High Range AED II - HR AED II - UTAK LABORATORIES, INC.

Duns Number:092519016

Device Description: HR AED II

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More Product Details

Catalog Number

72740

Brand Name

High Range AED II

Version/Model Number

72740

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code Details

Product Code

DIF

Product Code Name

Drug Mixture Control Materials

Device Record Status

Public Device Record Key

5c59bbfb-bb3f-4b4b-8e27-14d82b7c27d0

Public Version Date

April 23, 2020

Public Version Number

1

DI Record Publish Date

April 15, 2020

Additional Identifiers

Package DI Number

B800727405

Quantity per Package

5

Contains DI Package

B800727400

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"UTAK LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 113