PyloPlus+ Urea Breath Test Kit

GUDID 00860001810325

Arj Medical, Inc.

Carbon isotope breath test kit IVD

• Primary Device ID: 00860001810325
• NIH Device Record Key: 84eb304d-31c8-4185-8341-553c6880c0ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PyloPlus+ Urea Breath Test Kit
• Version Model Number: PPUBTK
• Company DUNS: 006808397
• Company Name: Arj Medical, 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: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• 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	00860001810325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170022

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-28
• Device Publish Date: 2025-01-20

Devices Manufactured by Arj Medical, Inc.

• 00860001810325 - PyloPlus+ Urea Breath Test Kit: 2025-01-28
• 00860001810325 - PyloPlus+ Urea Breath Test Kit: 2025-01-28
• 00860001810363 - PyloPlus+ Urea Breath Test Analyzer: 2025-01-28
• 00860001810370 - PyloPlus+ Urea Breath Test Pro Analyzer: 2025-01-28
• 00860001810387 - PyloPlus+ Urea Breath Test Lab Analyzer: 2025-01-28