Medistim Doppler probe PD110752

GUDID 07070554100740

Medistim ASA

Invasive vascular ultrasound system probe

• Primary Device ID: 07070554100740
• NIH Device Record Key: b5c320db-f948-4783-8225-17bdcb767a8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medistim Doppler probe
• Version Model Number: PD110752
• Catalog Number: PD110752
• Company DUNS: 519521751
• Company Name: Medistim ASA
• 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: 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	07070554100740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040228

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

[07070554100740]

Liquid Chemical;Hydrogen Peroxide;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-20
• Device Publish Date: 2016-09-15

Devices Manufactured by Medistim ASA

• 07070554102690 - Medistim MiraQ Vascular System: 2024-09-02
• 07070554103611 - Medistim MiraQ Vascular System: 2024-09-02
• 07070554103444 - Medistim MiraQ Vascular System: 2024-04-22
• 07070554104854 - Medistim System Activation Card: 2021-10-19
• 07070554104861 - Medistim System Activation Card: 2021-10-19
• 07070554104878 - Medistim System Activation Card: 2021-10-19
• 07070554104885 - Medistim System Activation Card: 2021-10-19
• 07070554104489 - Medistim Interconnect Cable: 2020-11-09