AccessGUDID - DEVICE: NA (00816765013168)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 710603
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 710603
Company Name: US Endoscopy

Primary DI Number: 00816765013168
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: The High Pressure Hose and Yoke for CO2 for use with US Endoscopy CO2 Insufflators in conjunction with medical grade CO2 cylinders with standard yoke connectors.

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?
14239	High-pressure medical gas hose	A length of flexible tube intended to deliver and withstand gases under very high pressure, e.g., greater than 200 bar/3000 pounds per square inch (psi). It may be composed of any of several malleable or semi-rigid materials (e.g., plastic, rubber, or nylon), and braided with cotton wool and/or stainless steel. It is typically used to transport high pressure compressed medical gas to a pressure regulating device. It is available in various lengths, including standard coil lengths. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCX	INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111648	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: 301ae9ae-bad8-434e-9dea-ced4ab6758f4
Public Version Date: July 04, 2022
Public Version Number: 5
DI Record Publish Date: September 17, 2016