Who else makes this device?

Name: Fujifilm
Brand: Fujifilm

Gastroenterology & Urology › DiagnosticInsufflator, Automatic Carbon-Dioxide For Endoscope

Fujifilm

This product is intended to be used in combination with the FUJIFILM endoscopic CO2 regulator GW-100, of which the Operation Manual lists the water tank WT-04G as a consumable supply in the…

Registry build 21.09.26

This product is intended to be used in combination with the FUJIFILM endoscopic CO2 regulator GW-100, of which the Operation Manual lists the water tank WT-04G as a consumable supply in the “Main Specifications” section. Do not use this product for any other purposes.

5manufacturers in China registered for this device type

5catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (3), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FCX
Manufacturer	City	Province	Registered as	Device types
Smartdata Suzhou Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	11
Zhejiang Chuangxiang Medical Technology Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	27
Jiana Sterilization Technology (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	23
Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.	Changzhou	Jiangsu	Manufacturer	14
Changzhou Endoclean Medical Device Co., Ltd.	Changzhou	Jiangsu	Repacker / relabeller	13

Record

Regulatory record for Fujifilm
Listed by	Fujifilm Corporation, Japan
FDA product code	FCX
Device type	Insufflator, Automatic Carbon-Dioxide For Endoscope
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K133976
Record published	2016-09-16
Record revised	2024-06-11 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization, High-level Disinfectant
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date, serial number
Storage	Handling environment temperature 10 to 40 °C; Storage environment temperature -10 to 45 °C; Special storage condition: There must be no condensation.; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 30 to 95 % RH
Packaging	Pack
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Fujifilm
Catalogue number	Size	Status
CT-11G		In distribution
WT-604G		In distribution
GW-100		In distribution
AW-604G		In distribution
WT-04G		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Insufflator, Automatic Carbon-Dioxide For Endoscope	Us Endoscopy	15
Irrigator/Insufflator	Pentax of America, Inc.	5
DIN 477 High Pressure Hose for CO2	Bracco Diagnostics, Inc.	3
East Coast Surgical Instruments	East Coast Surgical Inc.	3
Insufflator, Automatic Carbon-Dioxide For Endoscope	Richard Wolf Gmbh	3
CO2MPACT	Us Endoscopy	3
Endoscopic CO2 Regulation Unit	Olympus Medical Systems Corp.	3
Protocol Touch Colon Insufflator	Bracco Diagnostics, Inc.	3
Protocol Accessory Cart	Bracco Diagnostics, Inc.	2
High Pressure Hose and Yoke	Bracco Diagnostics, Inc.	2
Cylinder Hose	Olympus Medical Systems Corp.	2
Protocol Administration Set With Flexi-Cuff Retention Tip	Bracco Diagnostics, Inc.	2

Showing 12 of 38. All products under Insufflator, Automatic Carbon-Dioxide For Endoscope

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K180711	2018-05-25

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.