AERO DV®

GUDID 10884450030919

Merit Medical Systems, Inc.

Polymeric tracheal/bronchial stent, non-bioabsorbable, sterile

• Primary Device ID: 10884450030919
• NIH Device Record Key: be6930b1-d607-407b-bbec-faf9ffe0b41f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AERO DV®
• Version Model Number: 00884450030912
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00884450030912 [Primary]
GS1	10884450030919 [Package]; Contains: 00884450030912; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083625

FDA Product Code

• JCT: Prosthesis, tracheal, expandable

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: 2016-02-17

On-Brand Devices [AERO DV®]

• 10884450031015: 00884450031018
• 10884450031008: 00884450031001
• 10884450030995: 00884450030998
• 10884450030988: 00884450030981
• 10884450030971: 00884450030974
• 10884450030964: 00884450030967
• 10884450030957: 00884450030950
• 10884450030940: 00884450030943
• 10884450030933: 00884450030936
• 10884450030926: 00884450030929
• 10884450030919: 00884450030912
• 10884450030902: 00884450030905
• 10884450030896: 00884450030899
• 10884450030889: 00884450030882
• 10884450030872: 00884450030875
• 00884450690819: 00884450690819
• 00884450690741: 00884450690741
• 00884450690840: 00884450690840
• 00884450690789: 00884450690789
• 00884450691403: 00884450691403
• 00884450690864: 00884450690864
• 00884450690734: 00884450690734
• 00884450690857: 00884450690857
• 00884450690796: D
• 00884450690758: D
• 00884450690833: D