Adapter, Tube, Plexiglas, 1 1/2 TO 1 3/8 - Adapter, Tube, Plexiglas, 1 1/2 TO 1 3/8 - A-M SYSTEMS, LLC

Duns Number:020275145

Device Description: Adapter, Tube, Plexiglas, 1 1/2 TO 1 3/8

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More Product Details

Catalog Number

114000

Brand Name

Adapter, Tube, Plexiglas, 1 1/2 TO 1 3/8

Version/Model Number

Adapter, Plexiglas, 1 1/2 TO 1 3/8 - 114000

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

-

Product Code Details

Product Code

BYP

Product Code Name

Mouthpiece, Breathing

Device Record Status

Public Device Record Key

9a38642b-fe38-4547-91e3-eee1ba512ced

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

December 10, 2019

Additional Identifiers

Package DI Number

00817081022933

Quantity per Package

1

Contains DI Package

00817081022926

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"A-M SYSTEMS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 126