REBOA Catheter RB354070

GUDID 10887714024839

A coaxial catheter recommended for temporary occlusion of the aorta.

NUMED, INC.

Intravascular occluding balloon catheter, image-guided
Primary Device ID10887714024839
NIH Device Record Key5eb349b4-f887-433a-a78e-1dea628ee821
Commercial Distribution StatusIn Commercial Distribution
Brand NameREBOA Catheter
Version Model Number362
Catalog NumberRB354070
Company DUNS114186877
Company NameNUMED, 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

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110887714024839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJNCatheter, Intravascular Occluding, Temporary

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


[10887714024839]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2016-09-20

On-Brand Devices [REBOA Catheter]

10887714025256A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025249A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025232A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025225A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025218A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025201A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025195A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025188A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025171A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025164A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025157A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025140A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025133A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025126A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025119A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025102A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025096A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025089A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025072A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025065A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025058A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025041A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025034A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025027A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025010A coaxial catheter recommended for temporary occlusion of the aorta.
10887714025003A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024990A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024983A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024976A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024969A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024952A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024945A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024938A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024921A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024914A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024907A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024891A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024884A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024877A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024860A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024853A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024846A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024839A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024822A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024815A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024808A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024792A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024785A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024778A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024761A coaxial catheter recommended for temporary occlusion of the aorta.

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