SP 840 - 32021

GUDID 07071977000075

Memscap AS

Invasive-pressure external transducer, reusable

• Primary Device ID: 07071977000075
• NIH Device Record Key: 06c66755-6d82-47fa-92d0-5afd17bac9c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SP 840 - 32021
• Version Model Number: 0
• Company DUNS: 515343676
• Company Name: Memscap AS
• 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07071977000075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K792020

FDA Product Code

• DRS: Transducer, Blood-Pressure, Extravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

Devices Manufactured by Memscap AS

• 07071977000075 - SP 840 - 32021: 2018-07-06
• 07071977000075 - SP 840 - 32021: 2018-07-06
• 07071977000082 - Pressure dome - 30034: 2018-07-06