PTS® 613707

GUDID 04046964311055

PTS405 PTS BALLOON 40MM X 5CM X 80CM

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac sizing catheter
Primary Device ID04046964311055
NIH Device Record Key2715ac57-9574-4a16-b70c-0a6c974eee33
Commercial Distribution StatusIn Commercial Distribution
Brand NamePTS®
Version Model Number613707
Catalog Number613707
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
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temp
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temp
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temp
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temp
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temp
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temp
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temp
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temp
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temp
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temp
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temp
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temp
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temp
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS104046964311055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJNCatheter, intravascular occluding, temporary

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-11-02
Device Publish Date2016-08-09

On-Brand Devices [PTS®]

04046964311055PTS405 PTS BALLOON 40MM X 5CM X 80CM
04046964311031PTS404 PTS BALLOON 40MM X 4CM X 80CM
04046964311017PTS403 PTS BALLOON 40MM X 3CM X 80CM
04046964310997PTS305 PTS BALLOON 30MM X 5CM X 80 CM
04046964310973PTS304 PTS BALLOON 30MM X 4CM X 80CM
04046964310959PTS303 PTS BALLOON 30MM X 3CM X 80CM
04046964310935PTS253 PTS BALLOON 25MM X 3CM X 80CM
04046964310911PTS203 PTS BALLOON 20MM X 3CM X 80CM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.