AcQGuide Mini-S 012852

GUDID 00857042007500

AcQGuide Mini-S, 65cm - L2 with AcQCross QX

ACUTUS MEDICAL, INC.

Cardiac transseptal access set

• Primary Device ID: 00857042007500
• NIH Device Record Key: 9ddfac59-3206-4991-a732-c10362c8e9ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcQGuide Mini-S
• Version Model Number: 012852
• Catalog Number: 012852
• Company DUNS: 844418199
• Company Name: ACUTUS MEDICAL, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857042007500 [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: 2021-10-25
• Device Publish Date: 2021-10-15

Devices Manufactured by ACUTUS MEDICAL, INC.

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• 00850027837994 - FlexCath Cross Transseptal Solution: 2023-12-28
• 00850027837741 - FlexCath Cross Transseptal Solution: 2023-09-11 FlexCath Cross Transseptal Solution– AG 61 cm
• 00850027837765 - FlexCath Cross Transseptal Solution: 2023-09-11 FlexCath Cross Transseptal Solution– AG 71 cm
• 00850027837789 - FlexCath Cross Transseptal Solution: 2023-09-11 FlexCath Cross Transseptal Solution– SL 63 cm
• 00850027837802 - FlexCath Cross Transseptal Solution: 2023-09-11 FlexCath Cross Transseptal Solution– VZ 71 cm
• 00850027837826 - FlexCath Cross Transseptal Solution: 2023-09-11 FlexCath Cross Transseptal Solution– FC 65 cm