andorate® Air/Water Bottle Tubing with CO2 Extend

GUDID 14897106950147

GA Health Company Limited

Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use
Primary Device ID14897106950147
NIH Device Record Key76e095a5-045f-4fb8-9571-a235f3dd7894
Commercial Distribution StatusIn Commercial Distribution
Brand Nameandorate® Air/Water Bottle Tubing with CO2 Extend
Version Model NumberGAR088CO2EXTUS
Company DUNS686908512
Company NameGA Health Company Limited
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104897106950140 [Primary]
GS114897106950147 [Package]
Contains: 04897106950140
Package: Box [10 Units]
In Commercial Distribution
GS124897106950144 [Package]
Package: Carton [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCXEndoscopic Irrigation/Suction System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-01-07
Device Publish Date2020-05-28

On-Brand Devices [andorate® Air/Water Bottle Tubing with CO2 Extend]

14897106950185GAR090CO2EXTUS
14897106950147GAR088CO2EXTUS
14897106950086GAR072CO2EXTUS
14897106950048GAR025CO2EXTUS

Trademark Results [andorate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ANDORATE
ANDORATE
97445913 not registered Live/Pending
GA HEALTH COMPANY LIMITED
2022-06-07
ANDORATE
ANDORATE
97445874 not registered Live/Pending
GA HEALTH COMPANY LIMITED
2022-06-07
ANDORATE
ANDORATE
87709057 5589076 Live/Registered
GA HEALTH COMPANY LIMITED
2017-12-05

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