Performa® 7755-2M65

GUDID 10884450009915

Merit Medical Systems, Inc.

Angiographic catheter, single-use

• Primary Device ID: 10884450009915
• NIH Device Record Key: 9f77515b-a929-4fff-8500-e198ddbf4ca9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Performa®
• Version Model Number: 00884450009918
• Catalog Number: 7755-2M65
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450009918 [Primary]
GS1	10884450009915 [Package]; Contains: 00884450009918; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000659

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

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: 2016-09-24

On-Brand Devices [Performa®]

• 10884450408589: 00884450408582
• 10884450408572: 00884450408575
• 10884450394745: 00884450394748
• 10884450394721: 00884450394724
• 10884450383411: 00884450383414
• 10884450383404: 00884450383407
• 10884450363116: 00884450363119
• 10884450362942: 00884450362945
• 10884450362843: 00884450362846
• 10884450362836: 00884450362839
• 10884450362829: 00884450362822
• 10884450362805: 00884450362808
• 10884450362645: 00884450362648
• 10884450362638: 00884450362631
• 10884450362621: 00884450362624
• 10884450362577: 00884450362570
• 10884450362560: 00884450362563
• 10884450362553: 00884450362556
• 10884450362546: 00884450362549
• 10884450362225: 00884450362228
• 10884450362218: 00884450362211
• 10884450362195: 00884450362198
• 10884450362188: 00884450362181
• 10884450362164: 00884450362167
• 10884450362157: 00884450362150
• 10884450362102: 00884450362105
• 10884450362096: 00884450362099
• 10884450362089: 00884450362082
• 10884450362065: 00884450362068
• 10884450362041: 00884450362044
• 10884450362027: 00884450362020
• 10884450362003: 00884450362006
• 10884450360931: 00884450360934
• 10884450358877: 00884450358870
• 10884450356675: 00884450356678
• 10884450356606: 00884450356609
• 10884450356590: 00884450356593
• 10884450356583: 00884450356586
• 10884450356576: 00884450356579
• 10884450356569: 00884450356562
• 10884450356552: 00884450356555
• 10884450320751: 00884450320754
• 10884450320744: 00884450320747
• 10884450320737: 00884450320730
• 10884450320720: 00884450320723
• 10884450314798: 00884450314791
• 10884450309602: 00884450309605
• 10884450307004: 00884450307007
• 10884450306977: 00884450306970
• 10884450306823: 00884450306826