AccessGUDID - DEVICE: EndoSound® Air Leak Tester (00850050934110)

GUDID

Device Identifier (DI) Information

Brand Name: EndoSound® Air Leak Tester
Version or Model: 5030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5030
Company Name: Endosound, Inc.

Primary DI Number: 00850050934110
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 111281644 *Terms of Use

Device Description: The EndoSound Air Leak Tester is used with a UTM and pressure test cap to test the integrity of the UTM cable.

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?
38460	Invasive medical device leak tester, mechanical	A hand-operated device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It is typically a hand pump (e.g., a bulb) with a manometer and controls intended to be connected to the device tested. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCY	Bulb, Inflation, For Endoscope

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between -10 and 60 Degrees Celsius
Handling Environment Atmospheric Pressure: between 75 and 106 KiloPascal
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 75 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 699f723b-e2ef-42be-9362-87335e7e2bd6
Public Version Date: February 07, 2024
Public Version Number: 1
DI Record Publish Date: January 30, 2024