AccessGUDID - DEVICE: PDI® Lubricating Jelly II (00310819000499)

GUDID

Device Identifier (DI) Information

Brand Name: PDI® Lubricating Jelly II
Version or Model: T00250
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: T00250
Company Name: PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.

Primary DI Number: 00310819000499
Issuing Agency: GS1
Commercial Distribution End Date: December 06, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 800777117 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60796	General-body orifice lubricant	A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMJ	Lubricant, Patient

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 5.0 Gram

Device Record Status

Public Device Record Key: d061e91c-ecff-44eb-8024-338e7631e817
Public Version Date: November 28, 2022
Public Version Number: 3
DI Record Publish Date: October 09, 2020