Orthofuser

GUDID 10803622132190

LIVANOVA USA, INC.

Blood-processing autotransfusion system set

• Primary Device ID: 10803622132190
• NIH Device Record Key: ae391bd6-5c3f-4370-9390-be8fbbcc1085
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthofuser
• Version Model Number: Wound Drainage Set
• Company DUNS: 080914995
• Company Name: LIVANOVA USA, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00803622132193 [Primary]
GS1	10803622132190 [Package]; Contains: 00803622132193; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912019

FDA Product Code

• CAC: APPARATUS, AUTOTRANSFUSION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-15
• Device Publish Date: 2016-06-03

On-Brand Devices [Orthofuser]

• 10803622132190: Wound Drainage Set
• 10803622132183: Wound Drainage Set
• 10803622132176: Wound Drainage Set
• 10803622132169: Wound Drainage Set
• 10803622132152: Drain Line
• 00803622130816: Bracket
• 10803622130806: Orthofuser
• 10803622130790: Orthofuser
• 10803622130783: Orthofuser
• 10803622130776: Orthofuser
• 10803622130769: Orthofuser