Noseclip, Disposable , Blue, Rubber Pad - Noseclip, Disposable , Blue, Rubber Pad - A-M SYSTEMS, LLC

Duns Number:020275145

Device Description: Noseclip, Disposable , Blue, Rubber Pad

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More Product Details

Catalog Number

166910

Brand Name

Noseclip, Disposable , Blue, Rubber Pad

Version/Model Number

Noseclip, Blue, Rubber Pad - 166910

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

BXJ

Product Code Name

Clip, Nose

Device Record Status

Public Device Record Key

ad1c0009-1efd-4dac-ae8f-40c0f72b3e2b

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Additional Identifiers

Package DI Number

00817081026832

Quantity per Package

100

Contains DI Package

00817081026825

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