Follett - Plasma Freezer, upright, 25 cu ft, Rt hinge, - FOLLETT CORPORATION

Duns Number:002388445

Device Description: Plasma Freezer, upright, 25 cu ft, Rt hinge, heated door

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More Product Details

Catalog Number

01146786

Brand Name

Follett

Version/Model Number

FZR25-PL-RHT00S

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

85b96ff5-f32a-48a2-9059-cd6f38713085

Public Version Date

June 26, 2018

Public Version Number

3

DI Record Publish Date

February 14, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FOLLETT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 62