Retention Cuff Inflator 900405

GUDID 00815112021221

One Shot Cuff Inflator

BRACCO DIAGNOSTICS INC

Barium enema catheter
Primary Device ID00815112021221
NIH Device Record Key8d72e699-64c8-4505-a47e-e4ad70168e13
Commercial Distribution StatusIn Commercial Distribution
Brand NameRetention Cuff Inflator
Version Model Number900405
Catalog Number900405
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
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
GS100815112021221 [Unit of Use]
GS110815112021228 [Primary]
GS130815112021222 [Package]
Contains: 10815112021228
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-02
Device Publish Date2023-05-25

On-Brand Devices [Retention Cuff Inflator]

30815112020881One Shot Cuff Inflator
00815112021221One Shot Cuff Inflator

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