Blood Gas and Chemistry Analyzer

GUDID 06944413801875

Edan Instruments, Inc.

Metabolic profile clinical chemistry analyser IVD, stationary, semi-automated

• Primary Device ID: 06944413801875
• NIH Device Record Key: 7299c48f-9aa8-4587-ba41-ba56822db901
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Gas and Chemistry Analyzer
• Version Model Number: i15
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	06944413801875 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151978

FDA Product Code

• GLK: Control, Hematocrit

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

Devices Manufactured by Edan Instruments, Inc.

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• 06944413820470 - Holter ECG and ABP System: 2023-12-08
• 06944413820487 - Holter ECG and ABP System: 2023-12-08
• 06944413820494 - Holter ECG and ABP System: 2023-12-08
• 06944413820500 - Holter ECG and ABP System: 2023-12-08
• 06944413820562 - Electrocardiograph: 2023-12-08
• 06944413820616 - Electrocardiograph: 2023-12-08
• 06944413812680 - Ambulatory Blood Pressure Monitor: 2023-06-29