FDA.reportPublic FDA data

Aer-O-Scope Daily Tube Convenience Kit

Primary DI
17290016992028
Brand
Aer-O-Scope Daily Tube Convenience Kit
Company
G.I. VIEW LTD
Model
Rev B
Catalog number
MASA02502
Device description
This KIT is comprised of the daily water tube and the daily suction tube
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
17290016992028PackageGS16In Commercial Distribution
07290016992021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001699202817290016992028
07290016992021072900169920217290016992021

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
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
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
17290016992035Aer-O-Scope Water BottleRev AMASA024742017-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664925645NAHangzhou AGS MedTech Co., Ltd.FDF2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FDF2026-06-18
06973786293260Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293284Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293307Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293321Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-09
06973786293222Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
06973786293246Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
07290016992113Aer-O-Scope Disposable ColonoscopeG.I. VIEW LTDFDF2026-05-27
06959664925584NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15