PDI® Lubricating Jelly II - Lubricating jelly to lubricate the body orifices - PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.

Duns Number:800777117

Device Description: Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and th Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeutic devices.

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More Product Details

Catalog Number

T00250

Brand Name

PDI® Lubricating Jelly II

Version/Model Number

T00250

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 06, 2021

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KMJ

Product Code Name

Lubricant, Patient

Device Record Status

Public Device Record Key

d061e91c-ecff-44eb-8024-338e7631e817

Public Version Date

October 28, 2022

Public Version Number

2

DI Record Publish Date

October 09, 2020

Additional Identifiers

Package DI Number

10310819000496

Quantity per Package

72

Contains DI Package

00310819000499

Package Discontinue Date

December 06, 2021

Package Status

Not in Commercial Distribution

Package Type

Box

"PROFESSIONAL DISPOSABLES INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
U Unclassified 1