Micro Medical - MicroDiary - CAREFUSION U.K. 232 LIMITED

Duns Number:291555621

Device Description: MicroDiary

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More Product Details

Catalog Number

36-MD03-STK

Brand Name

Micro Medical

Version/Model Number

36-MD03-STK

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 22, 2019

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

-

Product Code Details

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Device Record Status

Public Device Record Key

626a3d87-1d6e-4045-827c-5e4b599ac195

Public Version Date

March 08, 2022

Public Version Number

5

DI Record Publish Date

August 04, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAREFUSION U.K. 232 LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 21