AccessGUDID - DEVICE: AquaShield (00724995183837)

GUDID

Device Identifier (DI) Information

Brand Name: AquaShield
Version or Model: 00711542
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00711542
Company Name: US Endoscopy

Primary DI Number: 00724995183837
Issuing Agency: GS1
Commercial Distribution End Date: November 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use
Previous DI: 00816765012451

Device Description: The AquaShield system is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures.

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":	Yes
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?
60738	Endoscopic insufflation tubing set, single-use	A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEQ	PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 42cb99ca-5b49-47c9-9978-f8e7208ad19b
Public Version Date: November 14, 2023
Public Version Number: 5
DI Record Publish Date: April 01, 2020