Mini Sheath with FlexCath Cross 012852-005

GUDID 00850027837697

Mini sheath, 65cm – L2 with FlexCath Cross

ACUTUS MEDICAL, INC.

Cardiac transseptal access set

• Primary Device ID: 00850027837697
• NIH Device Record Key: 0f57f4da-4080-416c-96ef-4ad8265a804d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini Sheath with FlexCath Cross
• Version Model Number: 012852-005
• Catalog Number: 012852-005
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850027837697 [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: 2023-09-08
• Device Publish Date: 2023-08-31

Devices Manufactured by ACUTUS MEDICAL, INC.

• 00850027837253 - DiamondTemp Generator Adapter: 2024-11-15 AcQMap to DiamondTemp Generator Adapter
• 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