Ameritus Oral Syringe - 1ml oral syringe - KENTEC MEDICAL, INC.

Duns Number:066175613

Device Description: 1ml oral syringe

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More Product Details

Catalog Number

AEG1-KMS-BA

Brand Name

Ameritus Oral Syringe

Version/Model Number

AEG1-KMS-BA

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

b86543df-a59e-44d1-9d8d-da4233133fae

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

June 03, 2020

Additional Identifiers

Package DI Number

20817522013258

Quantity per Package

500

Contains DI Package

10817522013251

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"KENTEC MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 44