Nut and Nipple, Swivel, B&W (Nitrogen) - Nut and Nipple, Swivel, B&W (Nitrogen) - A-M SYSTEMS, LLC

Duns Number:020275145

Device Description: Nut and Nipple, Swivel, B&W (Nitrogen)

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More Product Details

Catalog Number

159500

Brand Name

Nut and Nipple, Swivel, B&W (Nitrogen)

Version/Model Number

Nut and Nipple, (Nitrogen) - 159500

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

BZA

Product Code Name

Connector, Airway (Extension)

Device Record Status

Public Device Record Key

392f0918-e3d8-4de6-bd22-0c984d14f1a4

Public Version Date

October 21, 2020

Public Version Number

2

DI Record Publish Date

December 23, 2019

Additional Identifiers

Package DI Number

00817081023404

Quantity per Package

50

Contains DI Package

00817081023398

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