COEfficient™ 611246

GUDID 04046964334726

COE151 COEFFICIENT BALLOON 11 X 3 X 135

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac valvuloplasty catheter

Primary Device ID	04046964334726
NIH Device Record Key	b466deda-70ab-47af-9096-9c8fbc413672
Commercial Distribution Status	In Commercial Distribution
Brand Name	COEfficient™
Version Model Number	611246
Catalog Number	611246
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
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
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
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 *Store at room temp
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *Store at room temp
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *Store at room temp
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *Store at room temp
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *Store at room temp
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *Store at room temp
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *Store at room temp
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *Store at room temp
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *Store at room temp
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *Store at room temp
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *Store at room temp
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *Store at room temp
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *Store at room temp
Special Storage Condition, Specify	Between 0 and 0 *Keep away from sunlight
Special Storage Condition, Specify	Between 0 and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964334726 [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	2022-11-02
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

Trademark Results [COEfficient]

Mark Image Registration \| Serial	Company Trademark Application Date
COEFFICIENT 90115121 not registered Live/Pending	Coefficient Cycling LLC 2020-08-14
COEFFICIENT 90113986 not registered Live/Pending	Coefficient Cycling LLC 2020-08-14
COEFFICIENT 90045299 not registered Live/Pending	Verily Life Sciences LLC 2020-07-09
COEFFICIENT 87338179 not registered Live/Pending	Frictionless Systems, LLC 2017-02-16
COEFFICIENT 86300529 4667528 Live/Registered	Oceanus Automotive, LLC 2014-06-04
COEFFICIENT 78828699 not registered Dead/Abandoned	Standish Mellon Asset Management Company LLC 2006-03-03
COEFFICIENT 78027798 not registered Dead/Abandoned	Intrinsic Design, Inc. 2000-09-27
COEFFICIENT 75493234 2435611 Dead/Cancelled	BPI Inc. 1998-05-29
COEFFICIENT 75475244 2398381 Dead/Cancelled	Coefficient Limited Company 1998-04-27
COEFFICIENT 75403478 not registered Dead/Abandoned	Cadence Design Systems, Inc. 1997-12-09
COEFFICIENT 75403167 2276641 Dead/Cancelled	Cadence Design Systems, Inc. 1997-12-10
COEFFICIENT 74548120 1900565 Dead/Cancelled	Michelin Tire Corporation 1994-07-11