Elation™ P4L15/A

GUDID 10884450593834

Merit Medical Systems, Inc.

Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter

• Primary Device ID: 10884450593834
• NIH Device Record Key: bcca9526-c971-42ad-9a22-3a856fc47b9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elation™
• Version Model Number: 00884450593837
• Catalog Number: P4L15/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: 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 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	00884450593837 [Primary]
GS1	10884450593834 [Package]; Contains: 00884450593837; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213434

FDA Product Code

• KTI: Bronchoscope accessory

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: 2022-07-01
• Device Publish Date: 2022-06-23

On-Brand Devices [Elation™]

• 10884450399412: 00884450399415
• 10884450399368: 00884450399361
• 10884450399016: 00884450399019
• 10884450399009: 00884450399002
• 00884450398999: 00884450398999
• 10884450398989: 00884450398982
• 00884450398975: 00884450398975
• 10884450398965: 00884450398968
• 10884450398958: 00884450398951
• 10884450398941: 00884450398944
• 10884450398934: 00884450398937
• 10884450398927: 00884450398920
• 10884450398910: 00884450398913
• 10884450258146: 00884450258149
• 20884450258136: 00884450258132
• 20884450258129: 00884450258125
• 10884450258115: 00884450258118
• 10884450258108: 00884450258101
• 10884450258092: 00884450258095
• 20884450258082: 00884450258088
• 10884450258078: 00884450258071
• 20884450258068: 00884450258064
• 20884450258037: 00884450258033
• 10884450258016: 00884450258019
• 20884450258006: 00884450258002
• 10884450198053: 00884450198056
• 10884450198046: 00884450198049
• 10884450198039: 00884450198032
• 10884450198022: 00884450198025
• 10884450198015: 00884450198018
• 10884450198008: 00884450198001
• 10884450197995: 00884450197998
• 10884450197988: 00884450197981
• 10884450197971: 00884450197974
• 10884450197964: 00884450197967
• 10884450197957: 00884450197950
• 10884450197827: 00884450197820
• 10884450197810: 00884450197813
• 10884450197803: 00884450197806
• 10884450197780: 00884450197783
• 10884450197773: 00884450197776
• 10884450197766: 00884450197769
• 10884450399351: 00884450399354
• 10884450593834: 00884450593837