Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer - Isotemp Series -86C Freezer, 400 Box Capacity, - KEY SCIENTIFIC INC

Duns Number:938286804

Device Description: Isotemp Series -86C Freezer, 400 Box Capacity, 230V/50Hz

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More Product Details

Catalog Number

IUE40086LV

Brand Name

Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer

Version/Model Number

IUE40086LV

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

-

Product Code Details

Product Code

KSE

Product Code Name

Refrigerator, Freezer, Blood Storage

Device Record Status

Public Device Record Key

617a72f6-6be0-4638-9635-7d9e960a6ea7

Public Version Date

July 02, 2019

Public Version Number

1

DI Record Publish Date

June 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KEY SCIENTIFIC INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 255