ASAP® ASAP100/B

GUDID 10884450033002

Merit Medical Systems, Inc.

Thrombectomy suction catheter

• Primary Device ID: 10884450033002
• NIH Device Record Key: 5158d4b3-7c4f-4989-9e72-160370603bcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASAP®
• Version Model Number: 00884450033005
• Catalog Number: ASAP100/B
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, 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: false
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450033005 [Primary]
GS1	10884450033002 [Package]; Contains: 00884450033005; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100569

FDA Product Code

• DXE: Catheter, embolectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [ASAP®]

• 10884450033002: 00884450033005
• 10884450437268: 00884450437261
• 10884450511715: 00884450511718
• 10884450511708: 00884450511701
• 10884450568382: 00884450568385