HLS Set 701069081

GUDID 04058863078861

HIT Set Advanced 7.0, Adult, SOFTLINE Coating

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 04058863078861
• NIH Device Record Key: 465d67f7-c6f8-463d-a1e8-c0a33e509b31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HLS Set
• Version Model Number: BO-HLS 7050 USA
• Catalog Number: 701069081
• Company DUNS: 316153865
• Company Name: Maquet Cardiopulmonary AG
• 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: true
• 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 Dimensions

• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0
• Total Volume: 600 Milliliter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04058863078861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112360

FDA Product Code

• DTZ: Oxygenator, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-06
• Device Publish Date: 2021-07-29

On-Brand Devices [HLS Set]

• 04058863080383: HLS Set Advanced 7.0, Adult, BIOLINE Coating
• 04058863078861: HIT Set Advanced 7.0, Adult, SOFTLINE Coating
• 04058863076355: HLS Set Advanced 5.0, Small Adult, BIOLINE Coating
• 04037691588285: HKH 8870 Holder for priming bag