Assure® Slide Pill Swallowing Aid forte - Assure Slide Pill Swallowing Aid is for people - ARKRAY USA, INC.

Duns Number:008171162

Device Description: Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that h Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100025 is used as the assigned UDI for the Class I device.)

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More Product Details

Catalog Number

-

Brand Name

Assure® Slide Pill Swallowing Aid forte

Version/Model Number

1000002

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"

-

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

NXB

Product Code Name

Dispenser, Solid Medication

Device Record Status

Public Device Record Key

8023219d-6f53-4228-9636-04bd95a3d255

Public Version Date

July 23, 2020

Public Version Number

2

DI Record Publish Date

December 28, 2018

Additional Identifiers

Package DI Number

20015482100029

Quantity per Package

24

Contains DI Package

10015482100022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Shipper

"ARKRAY USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30
2 A medical device with a moderate to high risk that requires special controls. 50