Chilling Block UCB0002

GUDID 10854913006140

UROGEN PHARMA LTD

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• Primary Device ID: 10854913006140
• NIH Device Record Key: b2032b2e-f78b-48f3-a096-a780b1d9cb99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chilling Block
• Version Model Number: 2 syringes + 3 vials
• Catalog Number: UCB0002
• Company DUNS: 534155213
• Company Name: UROGEN PHARMA LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10854913006140 [Primary]
GS1	20854913006147 [Package]; Package: Carton Box [1 Units]; In Commercial Distribution

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-11
• Device Publish Date: 2022-02-03

On-Brand Devices [Chilling Block ]

• 10854913006089: 2 syringes + 2 vials
• 10854913006072: 2 syringes + 3 vials
• 10854913006140: 2 syringes + 3 vials