AcQCross Qx Integrated Transseptal Dilator/Needle

GUDID 00850027837574

ACUTUS MEDICAL, INC.

Cardiac transseptal access electrosurgical dilator/needle

• Primary Device ID: 00850027837574
• NIH Device Record Key: 8001c9dd-3777-4f28-b146-d473b7d38aa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcQCross Qx Integrated Transseptal Dilator/Needle
• Version Model Number: 900307
• 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	00850027837574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220047

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: 2022-03-01
• Device Publish Date: 2022-02-21

On-Brand Devices [AcQCross Qx Integrated Transseptal Dilator/Needle]

• 00850027837611: 900309
• 00850027837598: 900308
• 00850027837574: 900307
• 00850027837550: 900306