Blender - MICBLNDR,2-16 LPM,DISS,CE,LO - Carefusion Corporation

Duns Number:830432451

Device Description: MICBLNDR,2-16 LPM,DISS,CE,LO

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More Product Details

Catalog Number

-

Brand Name

Blender

Version/Model Number

10046A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

BZR

Product Code Name

Mixer, Breathing Gases, Anesthesia Inhalation

Device Record Status

Public Device Record Key

b8c2e6bf-799c-47c2-a830-7f62e93a32bd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAREFUSION CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 876
3 A medical device with high risk that requires premarket approval 29