COEfficient™ 611235

GUDID 04046964334504

COE140 COEFFICIENT BALLOON 5 X 4 X 135

B BRAUN INTERVENTIONAL SYSTEMS, INC

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