PDI® Lubricating Jelly II

Basic Information

• Brand Name: PDI® Lubricating Jelly II
• Primary DI: 00310819000482
• Version / Model: T00137
• Catalog Number: T00137
• Company Name: PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
• Labeler DUNS: 800777117
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-09
• Public Version: 3
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: ac1962dc-6cb6-4132-99f0-f4b2bb39bf07
• Distribution End Date: 2022-04-11

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KMJ	Lubricant, Patient	General Hospital	880.6375	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00310819000482	GS1
Package	10310819000489	GS1	Box	144	Not in Commercial Distribution	2022-04-11

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	2.7	Gram