Disposable PFT Nose Clip with Foam Pads - Disposable Pulmonary Function Testing Nose Clip - A-M SYSTEMS, LLC

Duns Number:020275145

Device Description: Disposable Pulmonary Function Testing Nose Clip with Foam Pads

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More Product Details

Catalog Number

166500

Brand Name

Disposable PFT Nose Clip with Foam Pads

Version/Model Number

Disposable PFT Nose Clip with Foam Pads - 166500

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

BXJ

Product Code Name

Clip, Nose

Device Record Status

Public Device Record Key

22492db2-a0da-4434-bf2c-fb7430945ec3

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

Additional Identifiers

Package DI Number

00817081022650

Quantity per Package

100

Contains DI Package

00817081021691

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