AcQGuide Flex 222852

GUDID 00857042007517

AcQGuide Flex RF 65 cm Med Curl

ACUTUS MEDICAL, INC.

Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set

• Primary Device ID: 00857042007517
• NIH Device Record Key: 1e5ed4dd-3c8b-48c2-81fb-d0878c8168aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcQGuide Flex
• Version Model Number: 222852
• Catalog Number: 222852
• 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	00857042007517 [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.

• 00850027837970 - FlexCath Cross Transseptal Solution: 2023-12-28
• 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
• 00850027837840 - FlexCath Cross Transseptal Solution: 2023-09-11 FlexCath Cross Transseptal Solution– MAX 70 cm