Orthofuser

GUDID 10803622130806

LIVANOVA USA, INC.

Blood-processing autotransfusion system container Blood-processing autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Red blood cell-recovery autotransfusion system container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container Autotransfusion system blood collection container

• Primary Device ID: 10803622130806
• NIH Device Record Key: 05fc074b-f869-45d7-83cb-28285458cab7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthofuser
• Version Model Number: Orthofuser
• 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	00803622130809 [Primary]
GS1	10803622130806 [Package]; Contains: 00803622130809; 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: 2016-03-10

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