FDA.reportPublic FDA data

N/A

Primary DI
04961333243051
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
EPSC004INT
Device description
FLOW UNIT 4
Published
2018-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NZAAccessories, Germicide, Cleaning, For Endoscopes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZAAccessories, Germicide, Cleaning, For EndoscopesGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040049000THE RELIANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation2004-12-17NZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333243051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333243051049613332430514961333243051

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic device sterilization/disinfection tubing setA collection of devices, or a preassembled device, intended to allow connection between the appropriate port(s) of a sterilizer/disinfector and the channels, ports or distal end of an endoscope or endoscopic device (e.g., ultrasound transducer) during device sterilization and/or disinfection. It typically includes appropriate tubing, adaptors, and connectors to allow the appropriate fluids (sterilant or disinfectant) and gases to flow through the device, and might include a flow management unit. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333225262DEFINAEPK-3000-US2018-04-16
04961333230594N/A9122D2017-04-06
04961333232154VIDEO BRONCHOSCOPEEB-1170K2017-04-06
04961333232161VIDEO BRONCHOSCOPEEB-1570K2017-04-06
04961333232178VIDEO BRONCHOSCOPEEB-1575K2017-04-06
04961333232185VIDEO BRONCHOSCOPEEB-1970K2017-04-06
04961333232192VIDEO BRONCHOSCOPEEB-1970TK2017-04-06
04961333232208ULTRASOUND BRONCHOSCOPEEB-1970UK2017-04-06
04961333232215VIDEO BRONCHOSCOPEEB-1975K2017-04-06
04961333232222VIDEO BRONCHOSCOPEEB-1990I2017-04-06
04961333232239VIDEO COLONOSCOPEEC-2990LI2017-04-06
04961333232253VIDEO COLONOSCOPEEC-3490LI2017-04-06
04961333232260VIDEO COLONOSCOPEEC-3490LK2017-04-06
04961333232277VIDEO COLONOSCOPEEC-3490TLI2017-04-06
04961333232284VIDEO COLONOSCOPEEC34-I10L2017-04-06
04961333232345VIDEO COLONOSCOPEEC-3890LI2017-04-06
04961333232352VIDEO COLONOSCOPEEC-3890LK2017-04-06
04961333232369VIDEO COLONOSCOPEEC-3890LZI2017-04-06
04961333232376VIDEO COLONOSCOPEEC-3890TLK2017-04-06
04961333232383VIDEO COLONOSCOPEEC38-I10L2017-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995193669RelianceCorporation Steris CanadaNZA2020-09-04
00724995193676RelianceCorporation Steris CanadaNZA2020-09-04
00724995193683RelianceCorporation Steris CanadaNZA2020-09-04
00724995193690RelianceCorporation Steris CanadaNZA2020-09-04
00724995193706RelianceCorporation Steris CanadaNZA2020-09-04
00724995194420NACorporation Steris CanadaNZA2020-04-30
04961333243044N/APENTAX OF AMERICA, INC.NZA2018-03-12
00724995002619NACorporation Steris CanadaNZA2017-04-15
00724995000639NACorporation Steris CanadaNZA2016-09-13
00724995001544NACorporation Steris CanadaNZA2016-09-13
00724995001551NACorporation Steris CanadaNZA2016-09-13
00724995087883NACorporation Steris CanadaNZA2016-09-13
00724995087890NACorporation Steris CanadaNZA2016-09-13
00724995087906NACorporation Steris CanadaNZA2016-09-13
00724995087913NACorporation Steris CanadaNZA2016-09-13
00724995087920NACorporation Steris CanadaNZA2016-09-13
00724995090630NACorporation Steris CanadaNZA2016-09-13
00724995152178RelianceCorporation Steris CanadaNZA2016-09-13
10724995083776RelianceSTERIS CORPORATIONNZA2016-09-08
50724995083774RelianceSTERIS CORPORATIONNZA2016-09-08