GravityPro - 100 mL Vented Oral / Enteral Syringe - NEOMED, INC.

Duns Number:799772079

Device Description: 100 mL Vented Oral / Enteral Syringe

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More Product Details

Catalog Number

NM-S100EOV

Brand Name

GravityPro

Version/Model Number

NM-S100EOV

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

7107cef4-2222-4d90-af07-c6aafea70b55

Public Version Date

October 29, 2021

Public Version Number

6

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

10817584010090

Quantity per Package

40

Contains DI Package

00817584010093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"NEOMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 183