SafeStraw™ Drinking Aid for Thick Liquid - SafeStraw, Blue, Thick Liquid - Bionix, LLC

Duns Number:117844489

Device Description: SafeStraw, Blue, Thick Liquid

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More Product Details

Catalog Number

212

Brand Name

SafeStraw™ Drinking Aid for Thick Liquid

Version/Model Number

212

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

-

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

ILC

Product Code Name

UTENSIL, EATING

Device Record Status

Public Device Record Key

4cda9eff-e35b-472b-8d45-feb76552176b

Public Version Date

January 14, 2022

Public Version Number

1

DI Record Publish Date

January 06, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIONIX, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 61
2 A medical device with a moderate to high risk that requires special controls. 27