FlexCath Cross Transseptal Solution 900300-003

GUDID 00850027837741

FlexCath Cross Transseptal Solution– AG 61 cm

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 Cardiac transseptal access electrosurgical dilator/needle

• Primary Device ID: 00850027837741
• NIH Device Record Key: 0a0723f3-cdcd-4c79-93ed-c0b97863b618
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexCath Cross Transseptal Solution
• Version Model Number: 900300-003
• Catalog Number: 900300-003
• 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: 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

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
• Phone: (442)232-6100
• Email: product.complaints@acutus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850027837741 [Primary]

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

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: 2023-09-11
• Device Publish Date: 2023-09-01

On-Brand Devices [FlexCath Cross Transseptal Solution]

• 00850027837925: FlexCath Cross Transseptal Solution– SL 81cm
• 00850027837901: FlexCath Cross Transseptal Solution– WT 75cm
• 00850027837888: FlexCath Cross Transseptal Solution– MH 81cm
• 00850027837864: FlexCath Cross Transseptal Solution– MH 63cm
• 00850027837840: FlexCath Cross Transseptal Solution– MAX 70 cm
• 00850027837826: FlexCath Cross Transseptal Solution– FC 65 cm
• 00850027837802: FlexCath Cross Transseptal Solution– VZ 71 cm
• 00850027837789: FlexCath Cross Transseptal Solution– SL 63 cm
• 00850027837765: FlexCath Cross Transseptal Solution– AG 71 cm
• 00850027837741: FlexCath Cross Transseptal Solution– AG 61 cm
• 00850027837994: 900311
• 00850027837970: 900310