Hematocrit Control

GUDID 06944413802018

Edan Instruments, Inc.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

• Primary Device ID: 06944413802018
• NIH Device Record Key: d35d807c-5eb0-4b69-88b3-e3c214e2c1bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hematocrit Control
• Version Model Number: High
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• Device Count: 5
• 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	06944413802018 [Primary]
GS1	06944413807891 [Unit of Use]

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.

• 06944413815889 - Patient Monitor: 2024-06-25
• 06944413815896 - Patient Monitor: 2024-06-25
• 06944413815902 - Patient Monitor: 2024-06-25
• 06944413813977 - ECG cable: 2024-06-06
• 06944413813984 - ECG cable: 2024-06-06
• 06944413813991 - ECG cable: 2024-06-06
• 06944413814004 - ECG cable: 2024-06-06
• 06944413814011 - ECG cable: 2024-06-06