GE

GUDID 00883489001320

GE Lancing device

BIONIME CORPORATION

Manual blood lancing device, reusable

• Primary Device ID: 00883489001320
• NIH Device Record Key: eccd5d56-1ab8-4e0a-b820-8aaad3cdc68e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GE
• 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	00883489001313 [Primary]
GS1	00883489001320 [Package]; Contains: 00883489001313; Package: paper [1 Units]; In Commercial Distribution
GS1	10883489001327 [Package]; Package: paper [48 Units]; In Commercial Distribution
GS1	20883489001324 [Package]; Contains: 10883489001327; Package: paper [12 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 [GE]

• 00883489310309: GE100
• 20883489001744: One box with 2 vials strip
• 20883489001720: 1 meter -00883489001719 1 vial of 10 pcs strip -00883489001757 1 lancing device -00883489001771
• 00883489001719: meter
• 20883489001706: 333
• 00883489001689: strip vial
• 10883489001662: 333
• 00883489001641: meter
• 00883489001443: GE100 Control Solution
• 00883489001436: GE100 Control Solution
• 00883489001399: GE100
• 20883489001386: GS550
• 20883489001362: GE100
• 20883489001348: GE100 Control Solution
• 20883489001287: GE100
• 20883489001263: GE100
• 20883489001249: GE100
• 20883489001225: GE100
• 20883489001201: GE100
• 00883489001177: GE100
• 20883489001485: GP200
• 20883489001829: GE333 control solution (High level)
• 20883489001805: GE333 control solution(Normal Level)
• 00883489001320: GE Lancing device
• 00883489002563: Kitbox