Chilling Block

Basic Information

• Brand Name: Chilling Block
• Primary DI: 10854913006089
• Version / Model: 2 syringes + 2 vials
• Company Name: UROGEN PHARMA LTD
• Labeler DUNS: 534155213
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-13
• Public Version: 4
• Public Version Date: 2021-02-04
• Public Version Status: Update
• Public Device Record Key: 18f4420a-c6eb-40da-af8c-ca9c46db989d
• Distribution End Date: 2021-02-03

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64149	Pharmaceutical cooling block	A non-powered, countertop device made of metal materials with high thermal conductivity designed to hold and maintain at low temperatures [e.g., between -3 and 5° Celsius] vials and syringes used to prepare pharmaceutical solutions in the pharmacy or laboratory. It is in the form of a solid unit with slots/compartments for placing the vials/syringes after it has been stored in a freezer, typically overnight. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10854913006089	GS1
Package	20854913006086	GS1	Carton Box	1	Not in Commercial Distribution	2021-02-03