ProtekSolo

GUDID 00814112020463

Three 25 cm Dilators (14 Fr, 18 Fr, and 22 Fr)

CARDIACASSIST, INC.

Vascular dilator, single-use Vascular dilator, single-use

• Primary Device ID: 00814112020463
• NIH Device Record Key: 0b13a349-9ce2-4f90-9643-df2f760a6f2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProtekSolo
• Version Model Number: 5100-1422
• Company DUNS: 948683941
• Company Name: CARDIACASSIST, INC.
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4129637770
• Email: gjohnson@tandemlife.com
• Phone: 4129637770
• Email: gjohnson@tandemlife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814112020463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162181

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-03
• Device Publish Date: 2017-05-22

On-Brand Devices [ProtekSolo]

• 00814112020463: Three 25 cm Dilators (14 Fr, 18 Fr, and 22 Fr)
• 00814112020449: 24 Fr x 60 cm venous cannula with 21 Fr Introducer