Prelude EASE™ PHR5F11021PW/F

GUDID 20884450525566

Merit Medical Systems, Inc.

Vascular dilator, single-use

• Primary Device ID: 20884450525566
• NIH Device Record Key: 809fe0d2-3dbe-4187-b0de-77e1a7883233
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelude EASE™
• Version Model Number: 10884450525569
• Catalog Number: PHR5F11021PW/F
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 5
• 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: true
• 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
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• 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
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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450525562 [Unit of Use]
GS1	10884450525569 [Primary]
GS1	20884450525566 [Package]; Contains: 10884450525569; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140543

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: 2021-04-08
• Device Publish Date: 2021-03-31

On-Brand Devices [Prelude EASE™]

• 20884450257931: 10884450257934
• 20884450257924: 10884450257927
• 20884450333826: 10884450333829
• 20884450289215: 10884450289218
• 20884450526143: 10884450526146
• 20884450526150: 10884450526153
• 20884450525986: 10884450525989
• 20884450525566: 10884450525569
• 20884450526181: 10884450526184
• 20884450526105: 10884450526108
• 20884450526112: 10884450526115
• 20884450525511: 10884450525514
• 20884450525979: 10884450525972
• 20884450524606: 10884450524609
• 20884450526006: 10884450526009
• 20884450526297: 10884450526290
• 20884450526327: 10884450526320
• 20884450525993: 10884450525996
• 20884450526198: 10884450526191
• 20884450526167: 10884450526160
• 20884450526389: 10884450526382
• 20884450524330: 10884450524333
• 20884450526341: 10884450526344
• 20884450526334: 10884450526337
• 20884450526228: 10884450526221
• 20884450333819: 10884450333812
• 20884450333796: 10884450333799
• 20884450306523: 10884450306526
• 20884450306370: 10884450306373
• 20884450306325: 10884450306328
• 20884450290020: 10884450290023
• 20884450289505: 10884450289508
• 20884450289499: 10884450289492
• 20884450289482: 10884450289485
• 20884450289475: 10884450289478
• 20884450289468: 10884450289461
• 20884450289451: 10884450289454
• 20884450289444: 10884450289447
• 20884450289437: 10884450289430
• 20884450289420: 10884450289423
• 20884450289413: 10884450289416
• 20884450289406: 10884450289409
• 20884450289390: 10884450289393
• 20884450289383: 10884450289386
• 20884450289376: 10884450289379
• 20884450289369: 10884450289362
• 20884450289352: 10884450289355
• 20884450289345: 10884450289348
• 20884450289338: 10884450289331
• 20884450289321: 10884450289324