612938

GUDID 04046964348983

SEAMLESS-5F-7CM NDL NT GW SS TIP-STD

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

Primary Device ID	04046964348983
NIH Device Record Key	fcbc5bdf-13a2-401f-9e31-6f01a9101772
Commercial Distribution Status	In Commercial Distribution
Version Model Number	612938
Catalog Number	612938
Company DUNS	784259751
Company Name	B BRAUN INTERVENTIONAL SYSTEMS, INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com
Phone	+1(877)836-2228
Email	GUDID.BBMUS_Service@bbraun.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0
Special Storage Condition, Specify	Between 0 and 0 *STORE AT ROOM TEMPERATURE.
Special Storage Condition, Specify	Between 0 and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964348983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K000737

FDA Product Code

DRE	DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-06-07
Device Publish Date	2016-08-09

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