NeoMed Oral Syringe - Sterile Oral Syringe, 12mL - NEOMED, INC.

Duns Number:799772079

Device Description: Sterile Oral Syringe, 12mL

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More Product Details

Catalog Number

BA-S12EO-S

Brand Name

NeoMed Oral Syringe

Version/Model Number

BA-S12EO-S

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

KYX

Product Code Name

Dispenser, Liquid Medication

Device Record Status

Public Device Record Key

d8b15d77-1784-4e60-92b2-2e44027c44f4

Public Version Date

October 29, 2021

Public Version Number

6

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

10817584010175

Quantity per Package

200

Contains DI Package

00817584010178

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