AccessGUDID - DEVICE: Aquilex® Fluid Control System (04056702002121)

GUDID

Device Identifier (DI) Information

Brand Name: Aquilex® Fluid Control System
Version or Model: AQL-100P
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: W.O.M. World of Medicine GmbH

Primary DI Number: 04056702002121
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316305242 *Terms of Use

Device Description: No description.

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?
36122	Hysteroscopic irrigation/insufflation system	A mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIG	Insufflator, Hysteroscopic

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
No Device Sizes

Device Record Status

Public Device Record Key: 82c62e23-a46e-4be5-acde-eed0be60df37
Public Version Date: December 05, 2022
Public Version Number: 4
DI Record Publish Date: August 10, 2016