Flex-Neck® CF-5443/A

GUDID 10884450170356

Merit Medical Systems, Inc.

Peritoneal dialysis catheter, chronic

Primary Device ID	10884450170356
NIH Device Record Key	ff63f761-8dea-451d-9b09-eafaccbe0e37
Commercial Distribution Status	In Commercial Distribution
Brand Name	Flex-Neck®
Version Model Number	00884450170359
Catalog Number	CF-5443/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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450170359 [Primary]
GS1	10884450170356 [Package] Contains: 00884450170359 Package: [30 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K070730

FDA Product Code

DRE	DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

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 [Flex-Neck®]

20884450375000	00884450375006
20884450334120	00884450334126
10884450330248	00884450330241
10884450330231	00884450330234
10884450330217	00884450330210
10884450330200	00884450330203
10884450330194	00884450330197
10884450330187	00884450330180
10884450330170	00884450330173
10884450330163	00884450330166
10884450330156	00884450330159
10884450330149	00884450330142
20884450330139	00884450330135
10884450330125	00884450330128
10884450330118	00884450330111
10884450330101	00884450330104
10884450330095	00884450330098
10884450330088	00884450330081
10884450330071	00884450330074
10884450330064	00884450330067
20884450305960	00884450305966
10884450305925	00884450305928
10884450305888	00884450305881
10884450305871	00884450305874
10884450305857	00884450305850
20884450252240	00884450252246
10884450170356	00884450170359
10884450170349	00884450170342
20884450170339	00884450170335
10884450170325	00884450170328
10884450170318	00884450170311
10884450170301	00884450170304
20884450170292	00884450170298
10884450170288	00884450170281
10884450170271	00884450170274
20884450170261	00884450170267
20884450170254	00884450170250
10884450170240	00884450170243
10884450170233	00884450170236
10884450170226	00884450170229
10884450170219	00884450170212
20884450170209	00884450170205
10884450170196	00884450170199
20884450170186	00884450170182
20884450170063	00884450170069
20884450170056	00884450170052
10884450170035	00884450170038
10884450170028	00884450170021
10884450305994	00884450305997
10884450727840	D

Trademark Results [Flex-Neck]

Mark Image Registration \| Serial	Company Trademark Application Date
FLEX-NECK 78154991 2729292 Live/Registered	MERIT MEDICAL SYSTEMS, INC. 2002-08-16
FLEX-NECK 73698519 1503041 Dead/Cancelled	MARPAC INDUSTRIES, INC. 1987-12-02
FLEX-NECK 73653418 not registered Dead/Abandoned	MARPAC INDUSTRIES, INC. 1987-04-06