FlexCath Cross Transseptal Solution

GUDID 00850027837994

ACUTUS MEDICAL, INC.

Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle

• Primary Device ID: 00850027837994
• NIH Device Record Key: a7f93dba-0bcb-4b08-b02d-24be544f0c81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexCath Cross Transseptal Solution
• Version Model Number: 900311
• Company DUNS: 844418199
• Company Name: ACUTUS MEDICAL, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850027837994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233691

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-28
• Device Publish Date: 2023-12-20

On-Brand Devices [FlexCath Cross Transseptal Solution ]

• 00850027837925: FlexCath Cross Transseptal Solution– SL 81cm
• 00850027837901: FlexCath Cross Transseptal Solution– WT 75cm
• 00850027837888: FlexCath Cross Transseptal Solution– MH 81cm
• 00850027837864: FlexCath Cross Transseptal Solution– MH 63cm
• 00850027837840: FlexCath Cross Transseptal Solution– MAX 70 cm
• 00850027837826: FlexCath Cross Transseptal Solution– FC 65 cm
• 00850027837802: FlexCath Cross Transseptal Solution– VZ 71 cm
• 00850027837789: FlexCath Cross Transseptal Solution– SL 63 cm
• 00850027837765: FlexCath Cross Transseptal Solution– AG 71 cm
• 00850027837741: FlexCath Cross Transseptal Solution– AG 61 cm
• 00850027837994: 900311
• 00850027837970: 900310