FDA.reportPublic FDA data

Air/Water Bottle CO2 Tubing

Primary DI
00850025860390
Brand
Air/Water Bottle CO2 Tubing
Company
Micro-tech Usa
Model
AW02-OLYC02
Device description
Air/Water Bottle CO2 Tubing Olympus
Published
2025-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OCXEndoscopic Irrigation/Suction System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850025860406PackageGS110In Commercial Distribution
00850025860413PackageGS14In Commercial Distribution
00850025860390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850025860406008500258604068500258604060850025860406
00850025860413008500258604138500258604130850025860413
00850025860390008500258603908500258603900850025860390

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Regulatory Flags#

DUNS number
079873914
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858276007700Polyp Trap single chamber bulkPT50-50-S2025-09-09
10858276007707Polyp Trap single chamber bulkPT50-50-S2025-09-09
00850025860857CO2 Source Tubing Adapter Olympus UCRBW02-CO2CONOLY2025-05-12
00850025860864CO2 Source Tubing Adapter Fuji GW100BW02-CO2CONFJ2025-05-12
00850025860901CO2 Source Tubing Filter Adapter OlympusBW02-CO2TUBAOLY2025-05-12
00858276007977CO2 Source Tubing Filter OlympusBW02-CO2TUBOLY2025-05-12
00858276007984Endoscopy Kit - Compliance+ FUJ5 KitKT1A0010A2025-05-12
10850025860854CO2 Source Tubing Adapter Olympus UCRBW02-CO2CONOLY2025-05-12
10850025860861CO2 Source Tubing Adapter Fuji GW100BW02-CO2CONFJ2025-05-12
10850025860908CO2 Source Tubing Filter Adapter OlympusBW02-CO2TUBAOLY2025-05-12
10858276007974CO2 Source Tubing Filter OlympusBW02-CO2TUBOLY2025-05-12
10858276007981Endoscopy Kit - Compliance+ FUJ5 KitKT1A0010A2025-05-12
00850025860802Scope Tip ProtectorBW03-DTPS2025-03-11
00850025860819Scope Tip ProtectorBW03-DTPL2025-03-11
10850025860809Scope Tip ProtectorBW03-DTPS2025-03-11
10850025860816Scope Tip ProtectorBW03-DTPL2025-03-11
00850025860420Irrigation Tubing SetAW02-OLYTUB2025-03-07
00850025860437Irrigation Tubing SetAW02-OLYTUB2025-03-07
00858276007557Sterile Bacteriostatic Lubricating GelMDJL1A0001A2025-03-05
00850025860451Air/Water Bottle TubingAW02-OLY2025-03-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809327356164ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356171ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356188ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356195ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
M84921890CleanCapture Aspiration CatheterHOBBS MEDICAL, INC.OCX2026-01-14
M710TCW51000Bayou™ troCarWash System Disposable KitBIOTEX, INC.OCX2025-10-10
14953170458429SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-09-30
00724995232177Fuji 700 4-piece Valve KitUS EndoscopyOCX2025-05-29
00850025860901CO2 Source Tubing Filter Adapter OlympusMicro-tech UsaOCX2025-05-12
00858276007977CO2 Source Tubing Filter OlympusMicro-tech UsaOCX2025-05-12
00850025860420Irrigation Tubing SetMicro-tech UsaOCX2025-03-07
00850025860451Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860772Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860789Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
00850025860796Irrigation Tubing SetMicro-tech UsaOCX2025-03-04
00850025860840Irrigation Tubing SetMicro-tech UsaOCX2025-03-04
00850025860307A/W Channel Cleaning Adapter + 4-Piece Valve KitMicro-tech UsaOCX2025-03-03
008500258603694-Piece Valve KitMicro-tech UsaOCX2025-03-03
008500258605813-Piece Valve KitMicro-tech UsaOCX2025-03-03
00858276007243Jacket Biopsy ValveMicro-tech UsaOCX2025-03-03
00858276007335Jacket Biopsy ValveMicro-tech UsaOCX2025-03-03
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.OCX2025-01-10
03700506320264ELUXEO Tubing KitNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02
03700506320271ELUXEO Tubing KitNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02
03700506320288ELUXEO TubingNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02
03700506320295ELUXEO TubingNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02
03700506320301ELUXEO TubingNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02