POCKET AIR - MICROBASE TECHNOLOGY CORP.

Duns Number:658434951

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More Product Details

Catalog Number

-

Brand Name

POCKET AIR

Version/Model Number

MBPN00207

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

Yes

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

BYP

Product Code Name

Mouthpiece, Breathing

Device Record Status

Public Device Record Key

8825c7d8-5b7a-4f69-9e73-d5ef0c9021ce

Public Version Date

June 11, 2020

Public Version Number

1

DI Record Publish Date

June 03, 2020

Additional Identifiers

Package DI Number

14719874690097

Quantity per Package

1400

Contains DI Package

04719874690090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MICROBASE TECHNOLOGY CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 4