FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04961333252121
Brand
PENTAX Medical
Company
HOYA CORPORATION
Model
OE-B14
Device description
PENTAX Medical Gas/Water Feeding Valve OE-B14
Published
2023-12-13
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
OCXEndoscopic Irrigation/Suction System
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232249000PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax of America, Inc.2023-12-01ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333252121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333252121049613332521214961333252121

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic procedure air/water valve, reusableA non-sterile device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] and/or water whilst preventing backflow. It is in the form of an attachable valve with one or more settings such as closed, insufflation (allowing air/gas in), and irrigation/rinse (allowing water in). This is a reusable device intended to be reprocessed prior to use.

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Moist Heat or Steam Sterilization""]"
High-level Disinfectant;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
691519705
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333227747PENTAXBS-LC12017-04-07
04961333228362PENTAXEG-3670URK2017-04-07
04961333228409PENTAXEG-3870UTK2017-04-07
04961333233793PENTAXEG-3270UK2018-08-10
04961333254316PENTAXEC-2990Li2024-07-26
04961333254323PENTAXEC34-i10L2024-07-26
04961333254330PENTAXEC-3890TLK2024-07-26
04961333254347PENTAXEC38-i10L2024-07-26
04961333254354PENTAXEC-3890Li2024-07-26
04961333254385PENTAXEG-2490K2024-07-26
04961333254392PENTAXEG27-i102024-07-26
04961333254408PENTAXEG-2990i2024-07-26
04961333254422PENTAXEG29-i102024-07-26
04961333254439PENTAXEG-3890TK2024-07-26
04961333255238VIVIDEOCP-10002025-12-19
04961333255306VIVIDEOVNL9-CP2025-12-19
04961333255191VIVIDEOCP-10002025-12-19
04961333255245VIVIDEOVNL9-CP2025-12-19
04961333254620PENTAX MedicalOE-B172024-12-13
04961333077731PENTAXOF-B1612023-07-31

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