Monarch® K05-00793B

GUDID 10884450236984

Merit Medical Systems, Inc.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 10884450236984
• NIH Device Record Key: 9572b49a-9c24-4ed7-9169-79f09bff3068
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch®
• Version Model Number: 00884450236987
• Catalog Number: K05-00793B
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450236987 [Primary]
GS1	10884450236984 [Package]; Contains: 00884450236987; Package: [5 Units]; In Commercial Distribution
GS1	20884450236981 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Product Code

• OEQ: Angiography/angioplasty kit

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: 2020-05-06
• Device Publish Date: 2018-09-13

On-Brand Devices [Monarch®]

• 20884450298064: 00884450298060
• 20884450298057: 00884450298053
• 20884450298040: 00884450298046
• 20884450298033: 00884450298039
• 10884450298029: 00884450298022
• 10884450236984: 00884450236987
• 20884450236967: 00884450236963
• 10884450236908: 00884450236901
• 20884450236875: 00884450236871
• 10884450236311: 00884450236314
• 20884450055476: 00884450055472
• 10884450017071: 00884450017074
• 10884450017064: 00884450017067
• 20884450016194: 00884450016190
• 10884450016180: 00884450016183
• 10884450006662: 00884450006665
• 20884450851764: D
• 20884450851757: D
• 10884450851729: D
• 20884450830691: A