AccessGUDID - DEVICE: PENTAX Medical (04961333252107)

GUDID

Device Identifier (DI) Information

Brand Name: PENTAX Medical
Version or Model: OE-B12
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HOYA CORPORATION

Primary DI Number: 04961333252107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 691519705 *Terms of Use

Device Description: PENTAX Medical Air/Water Feeding Valve OE-B12

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64640	Endoscope channel-opening adaptor	A small device intended to be manually attached to an endoscope channel/port (e.g., air/water channel, venting port), or an endoscope channel-opening button, to keep the channel open during sterilization/disinfection, typically to allow the luminal flow of a gas/solution or for pressure equalization between the endoscope interior and exterior (sterilizer chamber) to prevent damage. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement
FDS	Gastroscope And Accessories, Flexible/Rigid
FDF	Colonoscope And Accessories, Flexible/Rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231249	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1c9a433e-d445-4335-8c5a-6485a9b50cc8
Public Version Date: September 28, 2023
Public Version Number: 1
DI Record Publish Date: September 20, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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