NEOMED* - 20mL GPro Oral Syringe Orange Sterile - Avanos Medical, Inc.

Duns Number:079375431

Device Description: 20mL GPro Oral Syringe Orange Sterile

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More Product Details

Catalog Number

NM-S20EOV

Brand Name

NEOMED*

Version/Model Number

NM-S20EOV

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"

Yes

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

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

36cacf54-9e6a-43fe-b136-23fb1c7047e4

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

May 13, 2021

Additional Identifiers

Package DI Number

10350770002641

Quantity per Package

100

Contains DI Package

00350770002644

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"AVANOS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 269
2 A medical device with a moderate to high risk that requires special controls. 5221