ReSolve® RBDC-8-038/C

GUDID 10884450313302

Merit Medical Systems, Inc.

Biliary drainage catheter

• Primary Device ID: 10884450313302
• NIH Device Record Key: 98de7e03-15f8-402c-9ed3-f38de57c301c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReSolve®
• Version Model Number: 00884450313305
• Catalog Number: RBDC-8-038/C
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450313305 [Primary]
GS1	10884450313302 [Package]; Contains: 00884450313305; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141408

FDA Product Code

• FGE: CATHETER, BILIARY, DIAGNOSTIC

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: 2017-10-16

On-Brand Devices [ReSolve®]

• 10884450362997: 00884450362990
• 10884450362980: 00884450362983
• 10884450362973: 00884450362976
• 10884450362966: 00884450362969
• 10884450362959: 00884450362952
• 10884450361464: 00884450361467
• 10884450361457: 00884450361450
• 10884450361440: 00884450361443
• 10884450313302: 00884450313305
• 10884450313296: 00884450313299
• 10884450313289: 00884450313282
• 10884450313272: 00884450313275
• 10884450313265: 00884450313268
• 10884450313258: 00884450313251
• 10884450313241: 00884450313244
• 10884450313234: 00884450313237
• 10884450231644: 00884450231647
• 10884450231583: 00884450231586
• 10884450230258: 00884450230251
• 10884450230241: 00884450230244
• 10884450146108: 00884450146101
• 10884450145545: 00884450145548
• 10884450145538: 00884450145531
• 10884450145514: 00884450145517
• 10884450145507: 00884450145500
• 10884450145491: 00884450145494
• 10884450145484: 00884450145487
• 10884450145477: 00884450145470
• 10884450145460: 00884450145463
• 10884450145453: 00884450145456
• 10884450057565: 00884450057568
• 10884450057534: 00884450057537
• 10884450057503: 00884450057506
• 10884450057473: 00884450057476
• 10884450052331: 00884450052334
• 10884450018405: 00884450018408
• 10884450012823: 00884450012826
• 10884450012816: 00884450012819
• 10884450012809: 00884450012802
• 10884450012793: 00884450012796
• 10884450011505: 00884450011508
• 10884450009861: 00884450009864
• 10884450009854: 00884450009857
• 10884450009557: 00884450009550
• 10884450009540: 00884450009543
• 10884450009533: 00884450009536
• 10884450009526: 00884450009529
• 10884450009519: 00884450009512
• 10884450009502: 00884450009505
• 10884450009489: 00884450009482