AcQCross Qx 900301

GUDID 00850027837055

AcQCross Qx - AG 71cm

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: 00850027837055
• NIH Device Record Key: c6a2ee01-6b2f-4b5c-bbb6-9c897706c4f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcQCross Qx
• Version Model Number: 900301
• Catalog Number: 900301
• 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: false
• 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: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com
• Phone: (442)232-6100
• Email: product.complaints@acutus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850027837055 [Primary]

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: 2021-10-18
• Device Publish Date: 2021-10-08

On-Brand Devices [AcQCross Qx]

• 00850027837161: AcQCross Qx - MAX 70cm
• 00850027837147: AcQCross Qx - FC 65cm
• 00850027837123: AcQCross Qx - VZ 71cm
• 00850027837109: AcQCross Qx - SL 63cm
• 00850027837086: AcQCross Qx - AG 61cm
• 00850027837055: AcQCross Qx - AG 71cm