COEfficient™ 611233

GUDID 04046964334467

COE138 COEFFICIENT BALLOON 4 X 4 X 135

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac valvuloplasty catheter
Primary Device ID04046964334467
NIH Device Record Keybd2adb12-e78d-4279-be17-82055dd7e24a
Commercial Distribution Discontinuation2020-02-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCOEfficient™
Version Model Number611233
Catalog Number611233
Company DUNS784259751
Company NameB BRAUN INTERVENTIONAL SYSTEMS, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)836-2228
Email[email protected]

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT

Device Identifiers

Device Issuing AgencyDevice ID
GS104046964334467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MADCATHETER, PERCUTANEOUS (VALVULOPLASTY)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-25
Device Publish Date2016-08-09

On-Brand Devices [COEfficient™]

04046964334504COE140 COEFFICIENT BALLOON 5 X 4 X 135
04046964334467COE138 COEFFICIENT BALLOON 4 X 4 X 135

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