Z-6™ 611051

GUDID 04046955718054

Z6135 ATRIO BALLOON CATHETER 13.5MM

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac septostomy catheter, balloon
Primary Device ID04046955718054
NIH Device Record Key9bf4ec84-0dab-406e-b034-0d0152856e36
Commercial Distribution StatusIn Commercial Distribution
Brand NameZ-6™
Version Model Number611051
Catalog Number611051
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 Latexfalse
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
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

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
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Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
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Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
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Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
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Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
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Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
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Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
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Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
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Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
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Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
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Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 20 Degrees Celsius and 22 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP AWAY FROM SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0

Device Identifiers

Device Issuing AgencyDevice ID
GS104046955718054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXFCATHETER, SEPTOSTOMY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-13
Device Publish Date2021-09-04

On-Brand Devices [Z-6™]

04046955718054Z6135 ATRIO BALLOON CATHETER 13.5MM
04046955718047Z695 ATRIO BALLOON CATHETER 9.5MM

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