NeoMed Oral Syringe - Pharmacy Oral Dispenser, Amber, 12 mL - NEOMED, INC.

Duns Number:799772079

Device Description: Pharmacy Oral Dispenser, Amber, 12 mL

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More Product Details

Catalog Number

BA-S12EO

Brand Name

NeoMed Oral Syringe

Version/Model Number

BA-S12EO

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)

-

Over the Counter (OTC)

Yes

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

9a09f653-4294-4a16-ba68-5959b95ede87

Public Version Date

October 29, 2021

Public Version Number

6

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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