Micromax - MICROMAX LOW FLOW BLENDER, ARMSTONG - MAXTEC, LLC

Duns Number:169911828

Device Description: MICROMAX LOW FLOW BLENDER, ARMSTONG

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More Product Details

Catalog Number

-

Brand Name

Micromax

Version/Model Number

R203P13-008

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

2b838098-687d-4bb5-9c6e-620c5c3d15a9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 02, 2018

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