Blue Air Bulb Insufflator 900404

GUDID 10815112020870

Air Bulb Insufflator

BRACCO DIAGNOSTICS INC

Barium enema catheter
Primary Device ID10815112020870
NIH Device Record Key0e8071fd-14e7-48e4-a2bf-ffc4e16f899d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlue Air Bulb Insufflator
Version Model Number900404
Catalog Number900404
Company DUNS849234661
Company NameBRACCO DIAGNOSTICS INC
Device Count12
DM Exemptfalse
Pre-market Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100815112020873 [Unit of Use]
GS110815112020870 [Primary]
GS130815112020874 [Package]
Package: Box [12 Units]
In Commercial Distribution

FDA Product Code

FGDCatheter, Retention, Barium Enema With Bag

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-06-30
Device Publish Date2016-09-19

On-Brand Devices [Blue Air Bulb Insufflator]

10815112020870Air Bulb Insufflator
00815112021214Air Bulb Insufflator

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