CLEARSIGHT CSCM

GUDID 00690103193350

CLEARSIGHT FINGER CUFF MEDIUM MULTI PACK

Edwards Lifesciences LLC

Blood pressure cuff, single-use

• Primary Device ID: 00690103193350
• NIH Device Record Key: 5f19105c-071d-49fa-9e23-ebee23617154
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARSIGHT
• Version Model Number: CSCM
• Catalog Number: CSCM
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103193350 [Primary]
GS1	20690103193354 [Package]; Package: Shipper [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140312

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-03

On-Brand Devices [CLEARSIGHT]

• 00690103193367: CLEARSIGHT FINGER CUFF LARGE MULTI PACK
• 00690103193350: CLEARSIGHT FINGER CUFF MEDIUM MULTI PACK
• 00690103193343: CLEARSIGHT FINGER CUFF SMALL MULTI PACK
• 50690103199623: ClearSight Finger Cuff Large
• 50690103199616: ClearSight Finger Cuff
• 50690103199609: ClearSight Finger Cuff