FDA.reportPublic FDA data

CO2 Source Tubing Adapter Olympus UCR

Primary DI
00850025860857
Brand
CO2 Source Tubing Adapter Olympus UCR
Company
Micro-tech Usa
Model
BW02-CO2CONOLY
Device description
CO2 Source Tubing Adapter, Olympus UCR CO2 Insufflator, Non-Sterile.
Published
2025-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FFYAdaptor, Bulbs, Miscellaneous, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850025860854PackageGS11In Commercial Distribution
20850025860851PackageGS125In Commercial Distribution
00850025860857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002586085410850025860854
2085002586085120850025860851
00850025860857008500258608578500258608570850025860857

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, reusableA collection of flexible tubing intended to be used as a conduit to deliver a 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, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a reusable device.

Regulatory Flags#

DUNS number
079873914
Device count
1
DM exempt
true
Premarket 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
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
00850025860390Air/Water Bottle CO2 TubingAW02-OLYC022025-03-04
00850025860451Air/Water Bottle TubingAW02-OLY2025-03-04

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