Catalog Number

700-114

Brand Name

Self Oral Care Kit

Version/Model Number

700-114

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

912dda46-8218-4e6f-94b4-e0b363dfc92f

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

May 08, 2019

Package DI Number

50618029980033

Quantity per Package

12

Contains DI Package

00618029980038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case