FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04961333251049
Brand
PENTAX Medical
Company
HOYA CORPORATION
Model
OS-H5
Device description
PENTAX Water Bottle Assembly
Published
2024-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PEAEndoscope, accessories, image post-processing for color enhancement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333251025Direct MarkingGS10
04961333251049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333251025049613332510254961333251025
04961333251049049613332510494961333251049

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

Regulatory Flags#

DUNS number
691519705
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
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
04961333255801INSPIRAHOYA CORPORATIONPEA2025-06-20
04961333255825INSPIRAHOYA CORPORATIONPEA2025-06-20
04961333255818INSPIRAHOYA CORPORATIONPEA2025-06-20
04961333255832INSPIRAHOYA CORPORATIONPEA2025-06-20
04547410513790FUJIFILMFUJIFILM CORPORATIONPEA2025-05-31
04961333251605PENTAX MedicalHOYA CORPORATIONPEA2024-05-14
04961333251636PENTAX MedicalHOYA CORPORATIONPEA2024-05-14
04961333251025PENTAX MedicalHOYA CORPORATIONPEA2024-03-11
04961333254910INSPIRAHOYA CORPORATIONPEA2023-12-01
04961333254934INSPIRAHOYA CORPORATIONPEA2023-12-01
04961333249183DEFINAHOYA CORPORATIONPEA2023-10-31
04961333249176DEFINAHOYA CORPORATIONPEA2023-10-31
04961333251650PENTAX MedicalHOYA CORPORATIONPEA2023-10-31
04961333252145PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333252169PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251827PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251834PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251841PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333252107PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333252114PENTAX MedicalHOYA CORPORATIONPEA2023-09-20
04961333251858INSPIRAHOYA CORPORATIONPEA2023-09-20
04961333251896INSPIRAHOYA CORPORATIONPEA2023-09-20
04961333247974INSPIRAHOYA CORPORATIONPEA2023-09-16
04961333247929INSPIRAHOYA CORPORATIONPEA2023-09-16
04961333075157PENTAXHOYA CORPORATIONPEA2023-09-15
04961333247462PENTAX MedicalHOYA CORPORATIONPEA2023-09-15
04961333132607PENTAXHOYA CORPORATIONPEA2023-08-18
04961333070367PENTAXHOYA CORPORATIONPEA2023-07-31
04961333075164PENTAXHOYA CORPORATIONPEA2023-07-31
04961333077984PENTAXHOYA CORPORATIONPEA2023-07-31