PTS-X™ 613719

GUDID 04046955677283

PTSX306 PTS-X BALLOON 30MM X 3CM X 110CM

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter
Primary Device ID04046955677283
NIH Device Record Keya99493cc-4fa3-42ae-a10b-fb7e215afa03
Commercial Distribution StatusIn Commercial Distribution
Brand NamePTS-X™
Version Model Number613719
Catalog Number613719
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]
GS104046955677283 [Primary]

FDA Product Code

MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary
MJNCatheter, intravascular occluding, temporary

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-22
Device Publish Date2021-02-13

On-Brand Devices [PTS-X™]

04046955677405PTSX409 PTS-X BALLOON 40MM X 5CM X 110CM
04046955677382PTSX407 PTS-X BALLOON 40MM X 3CM X 110CM
04046955677368PTSX360 PTS-X BALLOON 35MM X 6CM X 110CM
04046955677344PTSX358 PTS-X BALLOON 35MM X 4CM X 110CM
04046955677320PTSX308 PTS-X BALLOON 30MM X 5CM X 110CM
04046955677306PTSX307 PTS-X BALLOON 30MM X 4CM X 110CM
04046955677283PTSX306 PTS-X BALLOON 30MM X 3CM X 110CM
04046955677245PTSX206 PTS-X BALLOON 20MM X 4CM X 110CM
04046955677221PTSX205 PTS-X BALLOON 20MM X 3CM X 110CM
04046955677269PTSX255 PTS-X BALLOON 25MM X 3CM X 110CM

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.