AccessGUDID - DEVICE: BEAMER AVEO IRRIGATION PUMP FOOT PEDAL REPLACEMENT PART (06946332803725)

GUDID

Device Identifier (DI) Information

Brand Name: BEAMER AVEO IRRIGATION PUMP FOOT PEDAL REPLACEMENT PART
Version or Model: PUMP-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Chongqing Jinshan Science & Technology (Group) Co., Ltd

Primary DI Number: 06946332803725
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 545245755 *Terms of Use

Device Description: FOOT PEDAL REPLACEMENT PART FOR AVEOPUMP

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?
58029	Foot-switch, pneumatic	A gas-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g. a pneumatic surgical saw, pneumatic wire driver, pneumatic surgical power tool system control unit) to which it is connected typically via one or more hoses and which is dependent upon pressurized gas [e.g., medical air, nitrogen (N2)]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCX	Endoscopic Irrigation/Suction System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210618	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: c7753a17-300c-4dca-bb51-32fcd5cbd78b
Public Version Date: January 01, 2024
Public Version Number: 2
DI Record Publish Date: February 22, 2022