GUDID 00840253108487

Water bottle cap with CO2, sterile


Endoscopic irrigation/distension bottle
Primary Device ID00840253108487
NIH Device Record Key4655eb6c-aa9e-4708-88e4-5ef504b8e2a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameHydra®
Version Model NumberSCT-609
Company DUNS021717889
Device Count10
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100840253108487 [Primary]
GS100840253111609 [Unit of Use]

FDA Product Code

FEQPump, Air, Non-Manual, For Endoscope


Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-27
Device Publish Date2016-09-08

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