Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA

GUDID 00857335005015

The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.

Otsuka America Pharmaceutical Inc

Helicobacter pylori urease IVD, kit, chromogenic

• Primary Device ID: 00857335005015
• NIH Device Record Key: fc55e2fc-77f8-45a4-8c0e-9b5f73c74be6
• Commercial Distribution Discontinuation: 2017-04-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA
• Version Model Number: 1.1
• Company DUNS: 008314390
• Company Name: Otsuka America Pharmaceutical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857335005015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100025

FDA Product Code

• OZA: Test, Urea Adult And Pediatric (Breath),

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

On-Brand Devices [Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA]

• 00857335005077: The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTe
• 00857335005015: The web based application for calculating pediatric urea hydrolysis rate as part of the BreathTe