HeartSpan® FCL16001

GUDID 00884450466728

Merit Medical Systems, Inc.

Cardiac transseptal access set

• Primary Device ID: 00884450466728
• NIH Device Record Key: 7926d9cd-78cb-44ef-b2bd-643ed0a2e13c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartSpan®
• Version Model Number: 00884450466728
• Catalog Number: FCL16001
• 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
• 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	00884450466728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132720

FDA Product Code

• DYB: INTRODUCER, CATHETER

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: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [HeartSpan®]

• 10884450489724: 00884450489727
• 10884450451714: 00884450451717
• 00884450451762: 00884450451762
• 00884450451755: 00884450451755
• 00884450451748: 00884450451748
• 00884450451731: 00884450451731
• 00884450451724: 00884450451724
• 00884450489413: 00884450489413
• 00884450489383: 00884450489383
• 00884450489376: 00884450489376
• 00884450489406: 00884450489406
• 00884450489710: 00884450489710
• 00884450465950: 00884450465950
• 00884450504826: 00884450504826
• 00884450465943: 00884450465943
• 00884450465936: 00884450465936
• 00884450465912: 00884450465912
• 00884450504840: 00884450504840
• 00884450466018: 00884450466018
• 00884450466025: 00884450466025
• 00884450489437: 00884450489437
• 00884450489451: 00884450489451
• 00884450489444: 00884450489444
• 00884450466728: 00884450466728
• 00884450466377: 00884450466377
• 00884450489468: 00884450489468
• 00884450489475: 00884450489475
• 00884450465929: 00884450465929
• 00884450489734: 00884450489734
• 00884450466278: 00884450466278
• 00884450504888: 00884450504888
• 00884450504864: 00884450504864
• 00884450466346: 00884450466346
• 00884450465905: 00884450465905
• 00884450465899: 00884450465899
• 00884450465998: 00884450465998
• 00884450465974: 00884450465974
• 00884450465967: 00884450465967
• 00884450504857: 00884450504857
• 00884450504833: 00884450504833
• 00884450630747: 00884450630747
• 00884450630754: 00884450630754
• 00884450630716: 00884450630716
• 00884450693704: 00884450693704
• 00884450693711: C
• 00884450466001: 00884450466001
• 00884450630723: C
• 00884450466384: A
• 00884450693698: C
• 00884450630730: C