Nagare

GUDID 00861705000425

Steerable Sheath, Bi-Directional

KALILA MEDICAL, INC.

Haemostasis valve

• Primary Device ID: 00861705000425
• NIH Device Record Key: 98529778-eafa-434b-8dda-3d72af9f4cd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nagare
• Version Model Number: SS8FMB74
• Company DUNS: 015986592
• Company Name: KALILA 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: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com
• Phone: +1-800-888-3786
• Email: TMCCustomer.admin@terumomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810591020222 [Previous]
GS1	00861705000425 [Primary]

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2018-05-29

Devices Manufactured by KALILA MEDICAL, INC.

• 00850021246082 - CrossWise: 2022-02-09 Steerable Transseptal Sheath
• 00861705000425 - Nagare: 2020-03-05Steerable Sheath, Bi-Directional
• 00861705000425 - Nagare: 2020-03-05 Steerable Sheath, Bi-Directional
• 00810591020215 - Vado: 2020-03-05 Steerable Sheath, Unidirectional (140 degrees)
• 00810591020222 - Vado: 2020-03-05 Steerable Sheath, Bidirectional
• 00810591020239 - Vado: 2020-03-05 Steerable Sheath, Unidirectional (200 degrees)