EmpowerMR® Injector System without Remote Control 017377

GUDID 47630039300973

Composed of: 1 x Hydraulic Controller 1 x Injector Head 1 x Electro-Hydraulic Interconnect

Bracco Injeneering SA

MRI contrast medium injection system, line-powered, stationary
Primary Device ID47630039300973
NIH Device Record Key251b8285-5aa9-4ca7-8309-798d95e6f355
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmpowerMR® Injector System without Remote Control
Version Model Number017377
Catalog Number017377
Company DUNS482489007
Company NameBracco Injeneering SA
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment
Special Storage Condition, SpecifyBetween 0 and 0 *Dry environment

Device Identifiers

Device Issuing AgencyDevice ID
GS147630039300973 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZQInjector, Contrast Medium, Automatic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-03
Device Publish Date2019-05-24

On-Brand Devices [EmpowerMR® Injector System without Remote Control ]

47630039300751Composed of : 1 x Electro-Hydraulic Interconnect GTIN : 37630039300365 1 x Hydraulic Controller
47630039300973Composed of: 1 x Hydraulic Controller 1 x Injector Head 1 x Electro-Hydraulic Interconnect

Trademark Results [EmpowerMR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EMPOWERMR
EMPOWERMR
77717847 3812745 Live/Registered
BRACCO INJENEERING S.A.
2009-04-20

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