Bottle Spike Type A

GUDID 37630039301492

Bottle Spike Type A

Bracco Injeneering SA

Contrast medium injection system syringe
Primary Device ID37630039301492
NIH Device Record Keyb9b3863c-f47a-47bd-bf76-57fe7671e012
Commercial Distribution StatusIn Commercial Distribution
Brand NameBottle Spike Type A
Version Model Number640458
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS117630039300002 [Previous]
GS117630039301498 [Primary]
GS137630039301492 [Package]
Contains: 17630039301498
Package: box [60 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZQInjector, Contrast Medium, Automatic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-14
Device Publish Date2020-05-06

Devices Manufactured by Bracco Injeneering SA

37630039302048 - Remote Control2024-06-06 EmpowerCTA+ Injector System, Remote Control
17630039301962 - Injector Head2024-05-06
17630039302037 - Injector Head2024-05-06
17630039301627 - FastLoad™ MR Syringe Pack 2024-04-16
37630039301980 - IV Pole2024-03-11
37630039301997 - Floor Stand2024-03-11
47630039301949 - EmpowerCTA+ Injector System2024-02-13 Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
47630039302014 - EmpowerCTA+ Injector System2023-10-25 Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector

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