FDA.reportPublic FDA data

Aer-O-Scope Water Bottle

Primary DI
17290016992035
Brand
Aer-O-Scope Water Bottle
Company
G.I. VIEW LTD
Model
Rev A
Catalog number
MASA02474
Device description
Water bottle and cap to be used exclusively with the Aer-O-Scope Colonoscope System
Published
2017-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDFColonoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016992035PackageGS12In Commercial Distribution
07290016992038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001699203517290016992035
07290016992038072900169920387290016992038

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video colonoscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy typically to examine the colon (e.g., diseases on the colon) or colon contents (e.g., blood in stools). It may be designed to be manually inserted or designed with features to assist/power insertion (e.g., push/pull double-balloons, powered propelling mechanism). Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97235753199eitan@giview.com

Regulatory Flags#

DUNS number
533751681
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290016992158SOLO SCOPE Disposable Colonoscope1MPK021512026-08-25
17290016992172SOLO SCOPE Video Controller1MPK021572026-08-25
07290016992113Aer-O-Scope Disposable ColonoscopeDMASA028002026-05-27
07290016992021Aer-O-Scope Daily Tube Convenience KitRev BMASA025022017-08-01
07290016992038Aer-O-Scope Water BottleRev AMASA024742017-08-01
07290016992007Aer-O-Scope WorkstationRev BMASA01012017-08-01
17290016992028Aer-O-Scope Daily Tube Convenience KitRev BMASA025022017-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974065750108EndofreshDaichuan Medical (Shenzhen) Co., LtdFDF2026-10-21
06974065750191EndofreshDaichuan Medical (Shenzhen) Co., LtdFDF2026-10-21
08809882470213ROBOPERA™ SETEndoRobotics Co., Ltd.FDF2026-10-16
08809882470220Articulated Basic Gripper GEndoRobotics Co., Ltd.FDF2026-10-16
08809882470237Articulated Dual Gripper GEndoRobotics Co., Ltd.FDF2026-10-16
08809882470381ROBOPERA™ UnitEndoRobotics Co., Ltd.FDF2026-10-16
08809882470398ROBOPERA™EndoRobotics Co., Ltd.FDF2026-10-16
08809882470404Controller AEndoRobotics Co., Ltd.FDF2026-10-16
08809882470428Controller BEndoRobotics Co., Ltd.FDF2026-10-16
08809882470442ROBOPERA™ AccessoriesEndoRobotics Co., Ltd.FDF2026-10-16
08809882470466R-Power CableEndoRobotics Co., Ltd.FDF2026-10-16
08809882470725ROBOPERA™ Storage CaseEndoRobotics Co., Ltd.FDF2026-10-16
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