GHT Test Strip

GUDID 00713757464802

GENESIS HEALTH TECHNOLOGIES, LLC

Glucose IVD, kit, electrometry

• Primary Device ID: 00713757464802
• NIH Device Record Key: 8e9a9850-f0df-418d-828a-378a76963633
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GHT Test Strip
• Version Model Number: TD-4123
• Company DUNS: 961576258
• Company Name: GENESIS HEALTH TECHNOLOGIES, LLC
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00713757464802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121224

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

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: 2018-03-29
• Device Publish Date: 2017-07-12

Devices Manufactured by GENESIS HEALTH TECHNOLOGIES, LLC

• 00713757465007 - GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM: 2020-01-31
• 00713757464802 - GHT Test Strip: 2018-03-29
• 00713757464802 - GHT Test Strip: 2018-03-29