Test Cartridge

GUDID 06944413802919

Edan Instruments, Inc.

Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE)

• Primary Device ID: 06944413802919
• NIH Device Record Key: 42f61fb2-4586-4b37-bdca-5aa3dc6ccc24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Test Cartridge
• Version Model Number: BG3
• Company DUNS: 529173163
• Company Name: Edan Instruments, 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413801950 [Package]; Package: [25 Units]; In Commercial Distribution
GS1	06944413802902 [Package]; Contains: 06944413801950; Package: [4 Units]; In Commercial Distribution
GS1	06944413802919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151978

FDA Product Code

• CHL: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [Test Cartridge]

• 06944413802940: BC4
• 06944413802919: BG3
• 06944413802865: BG8