Nasal Cannula, Non-Flare, Non-Crush Resistant - Nasal Cannula, Non-Flare, Non-Crush Resistant - A-M SYSTEMS, LLC

Duns Number:020275145

Device Description: Nasal Cannula, Non-Flare, Non-Crush Resistant

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More Product Details

Catalog Number

125000

Brand Name

Nasal Cannula, Non-Flare, Non-Crush Resistant

Version/Model Number

Nasal Cannula - 125000

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

CAT

Product Code Name

Cannula, Nasal, Oxygen

Device Record Status

Public Device Record Key

a3c7f93a-4200-45bf-a6f5-d01e70487496

Public Version Date

December 25, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2019

Additional Identifiers

Package DI Number

00817081023244

Quantity per Package

50

Contains DI Package

00817081023237

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