FDA.reportPublic FDA data

CO2 Source Tubing Adapter Fuji GW100

Primary DI
10850025860861
Brand
CO2 Source Tubing Adapter Fuji GW100
Company
Micro-tech Usa
Model
BW02-CO2CONFJ
Device description
CO2 Source Tubing Adapter, Fuji GW100 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
OTC
false
Sterile
false
Single use
false

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
10850025860861PackageGS11In Commercial Distribution
20850025860868PackageGS125In Commercial Distribution
00850025860864PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002586086110850025860861
2085002586086820850025860868
00850025860864008500258608648500258608640850025860864

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079873914
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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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