Protocol Administration Set With Flexi-Cuff Retention Tip 390401

GUDID 10815112020160

Protocol Administration Set With Flexi-Cuff Retention Tip CO2 Delivery System for Colon Insufflation

BRACCO DIAGNOSTICS INC

Insufflation gas conditioning tubing set
Primary Device ID10815112020160
NIH Device Record Key56781b1b-ccdb-42f8-abd8-b8919ebe00bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameProtocol Administration Set With Flexi-Cuff Retention Tip
Version Model Number390401
Catalog Number390401
Company DUNS849234661
Company NameBRACCO DIAGNOSTICS INC
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 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

Device Dimensions

Catheter Gauge48 French

Device Identifiers

Device Issuing AgencyDevice ID
GS110815112020160 [Primary]
GS130815112020164 [Package]
Package: Box [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCXInsufflator, Automatic Carbon-Dioxide For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-06-30
Device Publish Date2016-09-19

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