COEfficient™ 611235

GUDID 04046964334504

COE140 COEFFICIENT BALLOON 5 X 4 X 135

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter

• Primary Device ID: 04046964334504
• NIH Device Record Key: 7450b07d-65fc-49e7-8884-081b543d2ee9
• Commercial Distribution Discontinuation: 2020-02-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: COEfficient™
• Version Model Number: 611235
• Catalog Number: 611235
• Company DUNS: 784259751
• Company Name: B BRAUN INTERVENTIONAL 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964334504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014124

FDA Product Code

• MAD: CATHETER, PERCUTANEOUS (VALVULOPLASTY)

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: 2020-03-25
• Device Publish Date: 2016-08-09

On-Brand Devices [COEfficient™]

• 04046964334504: COE140 COEFFICIENT BALLOON 5 X 4 X 135
• 04046964334467: COE138 COEFFICIENT BALLOON 4 X 4 X 135
• 04046964334771: COE154 COEFFICIENT BALLOON 12 X 4 X 135
• 04046964334740: COE152 COEFFICIENT BALLOON 11 X 4 X 135
• 04046964334696: COE150 COEFFICIENT BALLOON 10 X 4 X 135
• 04046964334665: COE148 COEFFICIENT BALLOON 9 X 4 X 135
• 04046964334634: COE147 COEFFICIENT BALLOON 9 X 3 X 135
• 04046964334627: COE146 COEFFICIENT BALLOON 8 X 4 X 135
• 04046964334580: COE144 COEFFICIENT BALLOON 7 X 4 X 135
• 04046964334559: COE143 COEFFICIENT BALLOON 7 X 3 X 135
• 04046964334542: COE142 COEFFICIENT BALLOON 6 X 4 X 135
• 04046964334528: COE141 COEFFICIENT BALLOON 6 X 3 X 135
• 04046964334481: COE139 COEFFICIENT BALLOON 5 X 3 X 135
• 04046964334443: COE137 COEFFICIENT BALLOON 4 X 3 X 135
• 04046964336324: COE132 BALLOON CATHETER
• 04046964336300: COE131 BALLOON CATHETER
• 04046964336287: COE130 BALLOON CATHETER
• 04046964336263: COE129 BALLOON CATHETER
• 04046964336249: COE128 BALLOON CATHETER
• 04046964334757: COE153 COEFFICIENT BALLOON 12 X 3 X 135
• 04046964334726: COE151 COEFFICIENT BALLOON 11 X 3 X 135
• 04046964334689: COE149 COEFFICIENT BALLOON 10 X 3 X 135
• 04046964334603: COE145 COEFFICIENT BALLOON 8 X 3 X 135
• 04046964334429: COE136 COEFFICIENT BALLOON 12 X 2
• 04046964334405: COE135 COEFFICIENT BALLOON 11 X 2
• 04046964334375: COE134 COEFFICIENT BALLOON 10MM X 2CM
• 04046964334368: COE133 COEFFICIENT BALLOON 9MM X 2CM
• 04046964334344: COE127 COEFFICIENT BALL 12MM X 4CM
• 04046964334320: COE126 COEFFICIENT BALL 12MM X 3CM
• 04046964334306: COE125 COEFFICIENT BALL 12MM X 2CM
• 04046964334283: COE124 COEFFICIENT BALL 11MM X 4CM
• 04046964334269: COE123 COEFFICIENT BALL 11MM X 3CM
• 04046964334245: COE122 COEFFICIENT BALL 11MM X 2CM
• 04046964334221: COE121 COEFFICIENT BALL 10MM X 4CM
• 04046964334207: COE120 COEFFICIENT BALL 10MM X 3CM
• 04046964334184: COE119 COEFFICIENT BALL 10MM X 2CM
• 04046964334160: COE118 COEFFICIENT BALL 9MM X 4CM
• 04046964334153: COE117 COEFFICIENT BALL 9MM X 3CM
• 04046964334122: COE116 COEFFICIENT BALL 9MM X 2CM
• 04046964334108: COE115 COEFFICIENT BALL 8MM X 4CM
• 04046964334085: COE114 COEFFICIENT BALL 8MM X 3CM
• 04046964334078: COE113 COEFFICIENT BALL 8MM X 2CM
• 04046964334047: COE112 COEFFICIENT BALL 7MM X 4CM
• 04046964334023: COE111 COEFFICIENT BALL 7MM X 3CM
• 04046964334016: COE110 COEFFICIENT BALL 7MM X 2CM
• 04046964333996: COE109 COEFFICIENT BALL 6MM X 4CM
• 04046964333965: COE108 COEFFICIENT BALL 6MM X 3CM
• 04046964333941: COE107 COEFFICIENT BALL 6MM X 2CM
• 04046964333934: COE106 COEFFICIENT BALL 5MM X 4CM
• 04046964333903: COE105 COEFFICIENT BALL 5MM X 3CM