DG Health

GUDID 00023513487441

OTC Single Use urinary test strip

REESE PHARMACEUTICAL COMPANY

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• Primary Device ID: 00023513487441
• NIH Device Record Key: f544fa20-aa9a-45a7-9991-c53f6b64ef13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DG Health
• Version Model Number: UTES
• Company DUNS: 004172052
• Company Name: REESE PHARMACEUTICAL COMPANY
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com
• Phone: 216-231-6441
• Email: jake.blake@reesechemical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00023513487441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063295

FDA Product Code

• LJX: Test, Urine Leukocyte

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-12-22
• Device Publish Date: 2020-06-01

Devices Manufactured by REESE PHARMACEUTICAL COMPANY

• 10023513132140 - Reese's ColoTest: 2024-01-31
• 00023513487441 - DG Health: 2021-12-22OTC Single Use urinary test strip
• 00023513487441 - DG Health: 2021-12-22 OTC Single Use urinary test strip
• 00023513000039 - TopCare: 2020-08-24 OTC Single Use urinary test strip