FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04961333252114
Brand
PENTAX Medical
Company
HOYA CORPORATION
Model
OE-B13
Device description
PENTAX Medical Suction Control Valve OE-B13
Published
2023-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FDFColonoscope And Accessories, Flexible/Rigid
FDSGastroscope And Accessories, Flexible/Rigid
PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333252114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333252114049613332521144961333252114

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope suction valve, reusableA device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a reusable device.

Sterilization Methods#

Method table
Method
High-level Disinfectant
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
691519705
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14961333079343PENTAXOF-B1732023-07-31
14961333085535PENTAXOE-A412023-07-31
14961333232960PENTAX MedicalOE-A622023-07-31
04961333084753PENTAXOF-B802023-07-31
04961333225569PENTAX MedicalEB19-J10U2020-07-17
04961333239825VIVIDEOCP-10002024-02-07
04961333244744DEFINAEPK-30002020-07-17
04961333245888PENTAX MedicalEG34-i102020-07-17
04961333246632PENTAX MedicalED32-i102022-02-02
04961333246779PENTAXEC-3890Li2025-04-04
04961333246830PENTAXEC38-i10L2025-04-04
04961333246847PENTAXEG-2990i2025-04-04
04961333246939PENTAXEG29-i102025-04-04
04961333248056PENTAX MedicalVNL11-J102022-02-02
04961333248063PENTAX MedicalVNL8-J102022-02-02
04961333248070PENTAX MedicalVNL15-J102022-02-02
04961333248148PENTAXEC-3890Li2020-12-14
04961333248179PENTAXEG-2990i2020-12-14
04961333248209PENTAXEC38-i10L2020-12-14
04961333248315PENTAXEG29-i102020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664925645NAHangzhou AGS MedTech Co., Ltd.FDF2026-06-18
06959664925645NAHangzhou AGS MedTech Co., Ltd.FDS2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FDS2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FDF2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925584NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FDF2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15