RIGHTEST

GUDID 00883489001306

single lancing device

BIONIME CORPORATION

Manual blood lancing device, reusable

• Primary Device ID: 00883489001306
• NIH Device Record Key: 977bacf7-ed4f-4faf-8690-da4d05ad5bac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIGHTEST
• Version Model Number: GD500
• Company DUNS: 658637244
• Company Name: BIONIME CORPORATION
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883489001290 [Primary]
GS1	00883489001306 [Package]; Contains: 00883489001290; Package: paper [1 Units]; In Commercial Distribution
GS1	10883489001303 [Package]; Package: paper [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221062

FDA Product Code

• QRL: Multiple Use Blood Lancet For Single Patient Use Only

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: 2023-07-11
• Device Publish Date: 2023-07-03

On-Brand Devices [RIGHTEST]

• 00883489310293: GM250
• 00883489001603: GC300
• 00883489001498: GS100
• 20883489001461: GP200
• 20883489001423: GS100
• 00883489001405: GS300
• 20883489001164: GS550
• 20883489001140: GM550
• 00883489001078: GS100
• 20883489001065: GM100
• 00883489001047: GC300
• 20883489001034: GS300
• 00883489001009: GM300
• 00883489002037: 25 pcs strips(80883489002033) per vial, 2 vials(00883489002037) per box
• 00883489001993: 1 meter - 00883489001986 1 lancing device - 00883489002013 1 control solution -00883489002020
• 00883489001306: single lancing device