Merit MAK™ MAK001N-80/A

GUDID 10884450035587

Merit Medical Systems, Inc.

Vascular dilator, single-use

• Primary Device ID: 10884450035587
• NIH Device Record Key: d86b21ea-d577-4bb2-b600-9c878e54bd5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merit MAK™
• Version Model Number: 00884450035580
• Catalog Number: MAK001N-80/A
• 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: 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450035580 [Primary]
GS1	10884450035587 [Package]; Contains: 00884450035580; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031691

FDA Product Code

• DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

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: 2017-02-08

On-Brand Devices [Merit MAK™]

• 10884450155025: 00884450155028
• 10884450154899: 00884450154892
• 10884450144425: 00884450144428
• 10884450144418: 00884450144411
• 10884450144395: 00884450144398
• 10884450094799: 00884450094792
• 10884450094782: 00884450094785
• 10884450094768: 00884450094761
• 10884450094751: 00884450094754
• 10884450094744: 00884450094747
• 10884450094737: 00884450094730
• 10884450094720: 00884450094723
• 10884450094713: 00884450094716
• 10884450035587: 00884450035580
• 10884450028527: 00884450028520
• 10884450022044: 00884450022047
• 10884450022037: 00884450022030
• 10884450013264: 00884450013267
• 10884450012854: 00884450012857
• 10884450012847: 00884450012840
• 10884450012830: 00884450012833
• 10884450012724: 00884450012727
• 10884450012717: 00884450012710
• 10884450012700: 00884450012703
• 10884450012694: 00884450012697
• 20884450012684: 00884450012680
• 20884450012677: 00884450012673
• 10884450012601: 00884450012604
• 10884450012595: 00884450012598
• 10884450012588: 00884450012581
• 10884450012571: 00884450012574
• 10884450012564: 00884450012567
• 10884450012557: 00884450012550
• 10884450011451: 00884450011454
• 10884450008819: 00884450008812
• 10884450008789: 00884450008782
• 10884450008765: 00884450008768
• 10884450008758: 00884450008751
• 10884450008741: 00884450008744
• 10884450452285: 00884450452288
• 10884450144401: 00884450144404
• 10884450008772: A
• 10884450860318: T
• 10884450860301: T
• 10884450860295: T
• 10884450860288: T
• 10884450847326: C