Chilling Block

Basic Information

• Brand Name: Chilling Block
• Primary DI: 10854913006140
• Version / Model: 2 syringes + 3 vials
• Catalog Number: UCB0002
• Company Name: UROGEN PHARMA LTD
• Labeler DUNS: 534155213
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-03
• Public Version: 1
• Public Version Date: 2022-02-11
• Public Version Status: New
• Public Device Record Key: b2032b2e-f78b-48f3-a096-a780b1d9cb99

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	10854913006140	GS1
Package	20854913006147	GS1	Carton Box	1	In Commercial Distribution