HR Lubricating Jelly 2X

Basic Information

• Brand Name: HR Lubricating Jelly 2X
• Primary DI: 00851809002104
• Version / Model: 210
• Catalog Number: 210
• Company Name: HR PHARMACEUTICALS INC.
• Labeler DUNS: 828918164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-27
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 34e1f1b3-c94f-457b-bb6b-e7dbaebece3a

Device Description

Sterile Lubricating Jelly, Tube

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Liquid Chemical

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
Package	30851809002105	GS1	Case	192	In Commercial Distribution
Primary	00851809002104	GS1

Customer Contacts

• Phone: [phone] ext. 109
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	56.5	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius