seca mVSA 535 5351200131

GUDID 04012030019095

Spot-check-monitor inclusive blood pressure and Masimo Spo2 module.

seca GmbH & Co. KG

Multiple physiological parameter spot-check analysis system, clinical

• Primary Device ID: 04012030019095
• NIH Device Record Key: 1b99957e-66c6-4d1d-834f-63cd5ff124ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: seca mVSA 535
• Version Model Number: 535
• Catalog Number: 5351200131
• Company DUNS: 316584937
• Company Name: seca GmbH & Co. KG
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com
• Phone: +1(800)5427322
• Email: info.us@seca.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04012030019095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192092

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-09
• Device Publish Date: 2020-02-28

On-Brand Devices [seca mVSA 535]

• 04012030019545: Spot-check-monitor inclusive blood pressure, Masimo Spo2 and FILAC temperature module.
• 04012030019538: Spot-check-monitor inclusive blood pressure, Masimo Spo2 and FILAC temperature module.
• 04012030019125: Spot-check-monitor inclusive blood pressure and FILAC temperature module.
• 04012030019118: Spot-check-monitor inclusive blood pressure and FILAC temperature module.
• 04012030019095: Spot-check-monitor inclusive blood pressure and Masimo Spo2 module.