FDA.reportPublic FDA data

Fuse

Primary DI
00840253111180
Brand
Fuse
Company
ENDOCHOICE, INC.
Model
SCT-469-02
Catalog number
SCT-469-02
Device description
Reusable Water Bottle with CO2
Published
2017-08-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00840253111180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840253111180008402531111808402531111800840253111180

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic irrigation/distension bottleA device intended to be used during endoscopy procedures to provide a receptacle for irrigation water and a conduit for air/carbon dioxide (CO2) used for insufflation. It is typically in the form of an empty plastic bottle with a connector intended to attach to the proximal end of an endoscope and/or to a gas supply. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-632-3636customercare@endochoice.com

Regulatory Flags#

DUNS number
014154279
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840253110067Seal®SBC-5802017-11-06
00840253101068Seal®SBC-4602016-09-08
00816849010113Seal®SBC-3652016-09-08
00816849010120Seal®SBC-3662016-09-08
00840253103932FuseBoxFSP-100-ARFSP-100-AR2017-08-11
00840253104267FuseBoxLS-FSP-100LS-FSP-1002017-08-11
00840253104274FuseBoxLS-FSP-100-ARLS-FSP-100-AR2017-08-11
00840253109521Fuse®FDEMO-F75232016-09-08
00840253109538Fuse®FDEMO-F75242016-09-08
00840253109545Fuse®FDEMO-F75252016-09-08
00840253109552Fuse®FSC330-F75262016-09-08
00840253109576Fuse® FSC330-F7528FSC330-F75282016-09-08
00840253109583Fuse®FSC330-G75292016-09-08
00840253109590Fuse® FSC330-G75302016-09-08
00840253109606Fuse® FSC330-G75312016-09-08
00840253109811Fuse®FSG250-H76412016-09-08
00840253109828Fuse®FSG250-H76422016-09-08
00840253109835Fuse®FSC330-F75232016-09-08
00840253109842Fuse®FSC330-F75242016-09-08
00840253109859Fuse®FSC330-F75252016-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920295PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920394PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920462PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921599PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921742PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921759PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922176PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922183PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922190PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926068PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926099PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926112PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926136PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926143PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926150PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926228PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926273PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926280PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826927560PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826928420PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826928437PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25