Vado SS8FMB74

GUDID 00810591020222

Steerable Sheath, Bidirectional

KALILA MEDICAL, INC.

Haemostasis valve

• Primary Device ID: 00810591020222
• NIH Device Record Key: 11b48a0a-61fb-4d1e-b950-b3700b3c29d6
• Commercial Distribution Discontinuation: 2018-10-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vado
• Version Model Number: SS8FMB74
• Catalog 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(650)681-3470
• Email: aepcustomerservice@abbott.com
• Phone: +1(650)681-3470
• Email: aepcustomerservice@abbott.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810591020222 [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: 5
• Public Version Date: 2020-03-05
• Device Publish Date: 2017-05-19

On-Brand Devices [Vado]

• 00810591020239: Steerable Sheath, Unidirectional (200 degrees)
• 00810591020222: Steerable Sheath, Bidirectional
• 00810591020215: Steerable Sheath, Unidirectional (140 degrees)