Fuse®

GUDID 00840253101228

Water bottle cap with CO2, Reusable

ENDOCHOICE, INC.

Endoscopic irrigation/distension bottle
Primary Device ID00840253101228
NIH Device Record Key41ceb33b-cf57-4f81-ba50-8422d7a3e6fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuse®
Version Model NumberSCT-469
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 Datetrue
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
GS100840253101228 [Primary]

FDA Product Code

FDFColonoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2016-09-08

On-Brand Devices [Fuse®]

00816849019680Endoscopic Processor Unit
00816849019666Colonoscope
00840253101228Water bottle cap with CO2, Reusable
00840253101211Water bottle cap, reusable

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