AcQGuide MAX 900200-003

GUDID 00850027837666

12F AcQGuide MAX 2.0 Steerable Sheath

ACUTUS MEDICAL, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00850027837666
• NIH Device Record Key: 661bcf85-7fa5-424a-b846-6e8cbb8a847c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcQGuide MAX
• Version Model Number: 900200-003
• Catalog Number: 900200-003
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850027837666 [Primary]

FDA Product Code

• DRA: Catheter, Steerable

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: 2023-09-07
• Device Publish Date: 2023-08-30

On-Brand Devices [AcQGuide MAX]

• 00850027837017: 12F AcQGuide MAX 2.0 Steerable Sheath
• 00850027837666: 12F AcQGuide MAX 2.0 Steerable Sheath