seca 490 4900003001

GUDID 04012030017879

reusable cuffs (size L)

seca GmbH & Co. KG

Blood pressure cuff, reusable

• Primary Device ID: 04012030017879
• NIH Device Record Key: 40f9b818-f6f8-411e-bc99-53f1fb203700
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: seca 490
• Version Model Number: 490
• Catalog Number: 4900003001
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04012030017879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192092

FDA Product Code

• DXN: System, measurement, blood-pressure, non-invasive

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 490]

• 04012030017930: air tube extension for cuffs
• 04012030017886: reusable cuffs (size XL)
• 04012030017879: reusable cuffs (size L)
• 04012030017862: reusable cuffs (size M)
• 04012030017855: reusable cuffs (size S)
• 04012030018074: wall mounting solution for the seca mVSA 535 Vital Signs monitor