Excite™ HPC201E/A

GUDID 20884450380905

Merit Medical Systems, Inc.

Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing Radiographic procedure tubing

• Primary Device ID: 20884450380905
• NIH Device Record Key: f9f8b441-1c6c-4633-a0fb-5500de729297
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excite™
• Version Model Number: 00884450380901
• Catalog Number: HPC201E/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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450380901 [Primary]
GS1	10884450380908 [Package]; Contains: 00884450380901; Package: [25 Units]; In Commercial Distribution
GS1	20884450380905 [Package]; Contains: 10884450380908; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883718

FDA Product Code

• DXJ: DISPLAY, CATHODE-RAY TUBE, MEDICAL

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: 2020-02-10
• Device Publish Date: 2020-01-31

On-Brand Devices [Excite™]

• 10884450381004: 00884450381007
• 10884450380991: 00884450380994
• 20884450380981: 00884450380987
• 10884450380977: 00884450380970
• 20884450380950: 00884450380956
• 10884450380939: 00884450380932
• 20884450380912: 00884450380918
• 10884450380892: 00884450380895
• 10884450380885: 00884450380888
• 10884450380878: 00884450380871
• 20884450105256: 00884450105252
• 10884450104344: 00884450104347
• 10884450030346: 00884450030349
• 10884450029234: 00884450029237
• 20884450027947: 00884450027943
• 10884450027933: 00884450027936
• 10884450027926: 00884450027929
• 10884450025663: 00884450025666
• 20884450024267: 00884450024263
• 10884450021429: 00884450021422
• 20884450021419: 00884450021415
• 20884450021402: 00884450021408
• 10884450011437: 00884450011430
• 20884450008571: 00884450008577
• 10884450380946: 00884450380949
• 20884450380929: 00884450380925
• 20884450380905: 00884450380901