Fuse SCT-468-02

GUDID 00840253111173

Reusable Water Bottle

ENDOCHOICE, INC.

Endoscopic irrigation/distension bottle
Primary Device ID00840253111173
NIH Device Record Key5b0bea17-d0d2-474e-9845-82c040ddfa9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuse
Version Model NumberSCT-468-02
Catalog NumberSCT-468-02
Company DUNS014154279
Company NameENDOCHOICE, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-632-3636
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100840253111173 [Primary]

FDA Product Code

FDFColonoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840253111173]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2017-08-11

On-Brand Devices [Fuse]

00840253111180Reusable Water Bottle with CO2
00840253111173Reusable Water Bottle

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