Catalog Number

AEG10-KMS-BA

Brand Name

Ameritus Oral Syringe

Version/Model Number

AEG10-KMS-BA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

KYX

Product Code Name

Dispenser, Liquid Medication

Public Device Record Key

d5c89a5e-2e25-40ee-ae2d-d006758e47d1

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

June 03, 2020

Package DI Number

20817522013289

Quantity per Package

500

Contains DI Package

10817522013282

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box