Suction tip

GUDID 10803622105835

LIVANOVA USA, INC.

Surgical/emergency suction cannula, non-illuminating, single-use

• Primary Device ID: 10803622105835
• NIH Device Record Key: 8a27a529-95a5-4d38-8b27-978e56de6ecf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suction tip
• Version Model Number: SU-xxxxx
• Company DUNS: 080914995
• Company Name: LIVANOVA USA, 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: 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	00803622105838 [Primary]
GS1	10803622105835 [Package]; Contains: 00803622105838; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982891

FDA Product Code

• DTS: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

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: 2019-02-21
• Device Publish Date: 2015-07-16

On-Brand Devices [Suction tip]

• 10803622105910: SU-xxxxx
• 10803622105903: SU-xxxxx
• 10803622105897: SU-xxxxx
• 10803622105880: SU-xxxxx
• 10803622105873: SU-xxxxx
• 10803622105866: SU-xxxxx
• 10803622105859: SU-xxxxx
• 10803622105842: SU-xxxxx
• 10803622105835: SU-xxxxx
• 10803622105828: SU-xxxxx
• 10803622105811: SU-xxxxx
• 10803622105804: SU-xxxxx