B Medical Systems - Laboratory freezer - B Medical Systems SARL

Duns Number:377142935

Device Description: Laboratory freezer

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More Product Details

Catalog Number

991.8836.**

Brand Name

B Medical Systems

Version/Model Number

F900

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

JRM

Product Code Name

Freezer

Device Record Status

Public Device Record Key

14791236-7c7c-4eb1-9fe8-c93cc63d624c

Public Version Date

February 11, 2020

Public Version Number

2

DI Record Publish Date

February 08, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"B MEDICAL SYSTEMS SARL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 104
2 A medical device with a moderate to high risk that requires special controls. 104