AccessGUDID - DEVICE: FLUID CONTROL (04055207054628)

GUDID

Device Identifier (DI) Information

Brand Name: FLUID CONTROL
Version or Model: 2203011
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2203.011
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207054628
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: ARTHRO IRRIGATION PUMP 150MMHG for arthroscopy , for fluid management of irrigation fluid in joints, with instrument recognition, LCD Display, connection for footswitch and remote control, max. flushing performance 1.5ml/min, U: 100-240VAC, 50/60Hz, Dim. (wxhxd): 330x155x390mm

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):	No
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?
36664	Basic roller pump	A mains electricity (AC-powered) pump using rotating rollers which squeeze a soft-walled tubing against the housing wall, thus producing a pulsatile pumping effect. It is typically used for the delivery of precise quantities of liquids (e.g., for laboratory devices and equipment). For the roller pump used in open heart surgery see the appropriate GMDN code.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	ARTHROSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Pressure: 19.9983 KiloPascal

Device Record Status

Public Device Record Key: 7da3374c-271d-4c94-a146-c348d81a8d95
Public Version Date: May 24, 2023
Public Version Number: 5
DI Record Publish Date: July 21, 2017