22mm Adapter 22m/15f x 22m / 18f - 22mm Adapter 22m/15f x 22m / 18f - A-M SYSTEMS, LLC

Duns Number:020275145

Device Description: 22mm Adapter 22m/15f x 22m / 18f

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More Product Details

Catalog Number

153600

Brand Name

22mm Adapter 22m/15f x 22m / 18f

Version/Model Number

22mm Adapter 22m/15f x 22m / 18f - 153600

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)

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Device Record Status

Public Device Record Key

2f5dc995-4403-4745-98e8-9f5196d565c5

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

March 30, 2020

Additional Identifiers

Package DI Number

00817081026139

Quantity per Package

50

Contains DI Package

00817081026122

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