HLS Set 701069077

GUDID 04058863076355

HLS Set Advanced 5.0, Small Adult, BIOLINE Coating

Maquet Cardiopulmonary AG

Cardiopulmonary bypass system tubing set

• Primary Device ID: 04058863076355
• NIH Device Record Key: bbb5f4ee-59f0-4eba-bc68-4e32c97140c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HLS Set
• Version Model Number: BEQ-HLS 5050 USA
• Catalog Number: 701069077
• 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: true
• 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: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0
• Total Volume: 570 Milliliter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04058863076355 [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