Hydraulic Controller 017378

GUDID 37630039300990

Bracco Injeneering SA

MRI contrast medium injection system, line-powered, stationary
Primary Device ID37630039300990
NIH Device Record Key28e09015-a4e3-4515-982c-2a276f46403f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHydraulic Controller
Version Model Number017378
Catalog Number017378
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
GS117630039300996 [Primary]
GS137630039300990 [Package]
Contains: 17630039300996
Package: BOX [1 Units]
In Commercial Distribution

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 [Hydraulic Controller]

37630039300389017378
37630039300990017378

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.