MicroMax Blender - High Flow DISS Armstrong - MAXTEC, LLC

Duns Number:169911828

Device Description: High Flow DISS Armstrong

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More Product Details

Catalog Number

-

Brand Name

MicroMax Blender

Version/Model Number

R203P14-008

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K053232

Product Code Details

Product Code

BZR

Product Code Name

Mixer, Breathing Gases, Anesthesia Inhalation

Device Record Status

Public Device Record Key

e3a717fb-4c32-4cce-a024-fb3fd2d99e84

Public Version Date

February 14, 2019

Public Version Number

1

DI Record Publish Date

January 14, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAXTEC, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 280
2 A medical device with a moderate to high risk that requires special controls. 235