HpOne GIS-64

GUDID 00893029002502

HpOne detects the urease enzyme for the presumptive identification of Helicobacter pylori in gastric mucosal biopsies. It is intended for in-vitro diagnostic use only.

GI Supply, Inc.

Helicobacter pylori urease IVD, reagent

• Primary Device ID: 00893029002502
• NIH Device Record Key: 75a94dab-3953-4626-93d1-d39a66a22c9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HpOne
• Version Model Number: GIS-64
• Catalog Number: GIS-64
• Company DUNS: 160990313
• Company Name: GI Supply, 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com
• Phone: 800-451-5797
• Email: info@gi-supply.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893029002502 [Primary]
GS1	10893029002509 [Package]; Package: Master [50 Units]; In Commercial Distribution
GS1	20893029002506 [Package]; Package: Dispenser [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012411

FDA Product Code

• LYR: Helicobacter Pylori

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: 2021-07-16
• Device Publish Date: 2021-07-08

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• 10893029002608 - MoonPants ML: 2021-07-28 MoonPants ML single-use non-sterile garment
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• 00893029002670 - SportShorts XS: 2021-07-28 SportShorts XS single-use non-sterile garment
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