612946

GUDID 04046964349140

SEAMLESS-5F-7CM NDL NT GW AU TIP-STIF

B BRAUN INTERVENTIONAL SYSTEMS, INC

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device ID04046964349140
NIH Device Record Key7dff9b00-f7a4-4845-b63e-1b508d3597ef
Commercial Distribution StatusIn Commercial Distribution
Version Model Number612946
Catalog Number612946
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 Kittrue
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
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 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *STORE AT ROOM TEMPERATURE.

Device Identifiers

Device Issuing AgencyDevice ID
GS104046964349140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2016-08-09

Devices Manufactured by B BRAUN INTERVENTIONAL SYSTEMS, INC

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04046955716630 - Seamless™2023-07-07 4F x 5CM MPK 2.5CM NDL-018 NT GW AU TIP-STIF
04046955805051 - Seamless™2023-07-07 21 GA X 4CM ECHO XSHARP TW INTRO NEEDLE
04046955805075 - Seamless™2023-07-07 21 GA X 7CM ECHO XSHARP TW INTRO NEEDLE
04046964290527 - Impact™2022-11-02 IMPACT BALLOON CATHETER 12 4 STD
04046964290534 - Impact™2022-11-02 IMPACT BALLOON CATHETER 12 4 STD
04046964290763 - Impact™2022-11-02 IMPACT BALLOON CATHETER 14MMX2CMX120CM

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