Flex-Neck® CC-2300/A

GUDID 10884450170028

Merit Medical Systems, Inc.

Peritoneal dialysis catheter adaptor, single-use

• Primary Device ID: 10884450170028
• NIH Device Record Key: 07b5c7b1-f753-45e1-aaa3-8a07fe7ae20e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex-Neck®
• Version Model Number: 00884450170021
• Catalog Number: CC-2300/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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450170021 [Primary]
GS1	10884450170028 [Package]; Contains: 00884450170021; Package: [1 Units]; In Commercial Distribution
GS1	20884450170025 [Package]; Package: [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974570

FDA Product Code

• FKO: CATHETER, PERITONEAL DIALYSIS, SINGLE USE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-22
• Device Publish Date: 2015-10-30

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