Adapter, NDD Syringe Adapter 2030-3 - Adapter, NDD Syringe Adapter 2030-3 - A-M SYSTEMS, LLC

Duns Number:020275145

Device Description: Adapter, NDD Syringe Adapter 2030-3

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More Product Details

Catalog Number

115617

Brand Name

Adapter, NDD Syringe Adapter 2030-3

Version/Model Number

NDD Syringe Adapter 2030-3, 115617

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Device Record Status

Public Device Record Key

0c97b942-8756-46dc-b632-dbf95bc19f81

Public Version Date

October 19, 2022

Public Version Number

1

DI Record Publish Date

October 11, 2022

Additional Identifiers

Package DI Number

00817081027389

Quantity per Package

1

Contains DI Package

00817081027372

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