FDA.reportPublic FDA data

N/A

Primary DI
04961333243044
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
EPSC001INT
Device description
FLOW UNIT 1
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
04961333243044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333243044049613332430444961333243044

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
00854924006255C2 CryoBalloon Ablation System FG-10252025-04-04
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333232550ULTRASOUND GASTROSCOPEEG-3670URK2017-04-06
04961333232567ULTRASOUND GASTROSCOPEEG-3870UTK2017-04-06
04961333233953ULTRASOUND GASTROSCOPEEG-3270UK2017-06-26
04961333231942VIDEO PROCESSOREPK-I5010-US2018-04-16
04961333232598VIDEO PROCESSOREPK-I50102017-04-06
04961333232604VIDEO PROCESSOREPK-I70102017-04-06
04961333242207N/A92026/102018-03-08
04961333242214N/A92026/252018-03-08
04961333242221N/A92026/32018-03-08
04961333242238N/A92026/502018-03-08
04961333242276N/A92052/202018-03-08
04961333242283N/A92052/62018-03-08
04961333242306N/A92092/122018-03-08
04961333242313N/A92092/252018-03-08

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
04961333243051N/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