InQwire® Amplatz IQA506

GUDID 10884450434632

Merit Medical Systems, Inc.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 10884450434632
• NIH Device Record Key: 4566d0ee-29a0-41af-9e41-16e9088609ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InQwire® Amplatz
• Version Model Number: 00884450434635
• Catalog Number: IQA506
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450434635 [Primary]
GS1	10884450434632 [Package]; Contains: 00884450434635; Package: [5 Units]; In Commercial Distribution
GS1	20884450434639 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170700

FDA Product Code

• DQX: Wire, guide, catheter

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: 2020-02-14
• Device Publish Date: 2020-02-06

On-Brand Devices [InQwire® Amplatz]

• 10884450355968: 00884450355961
• 20884450355958: 00884450355954
• 10884450335977: 00884450335970
• 20884450311510: 00884450311516
• 20884450311497: 00884450311493
• 10884450239800: 00884450239803
• 10884450239794: 00884450239797
• 10884450239787: 00884450239780
• 10884450239770: 00884450239773
• 20884450239760: 00884450239766
• 20884450239753: 00884450239759
• 10884450239749: 00884450239742
• 20884450239739: 00884450239735
• 10884450239718: 00884450239711
• 10884450239701: 00884450239704
• 10884450239695: 00884450239698
• 20884450239685: 00884450239681
• 10884450239671: 00884450239674
• 20884450239661: 00884450239667
• 10884450239503: 00884450239506
• 10884450239497: 00884450239490
• 10884450239473: 00884450239476
• 20884450239463: 00884450239469
• 20884450239456: 00884450239452
• 10884450434632: 00884450434635
• 20884450434622: 00884450434628
• 20884450434646: 00884450434642