AccessGUDID - DEVICE: Atmos (E261UDAELN0)

GUDID

Device Identifier (DI) Information

Brand Name: Atmos
Version or Model: UD-AELN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOENGINEERING LABORATORIES SRL

Primary DI Number: E261UDAELN0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 447644969 *Terms of Use

Device Description: Transparent extension line 1500mm

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:	Yes
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?
44675	Urological pressure monitoring tubing set	A collection of devices that includes the tubing and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used as an external connection for the invasive measurement of urethral and related urological pressures. This set will interface, either directly or from an intermediate stopcock, between the applied invasive catheter and the measuring transducer. It will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXQ	Cystometer, Electrical Recording

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 1500 Millimeter

Device Record Status

Public Device Record Key: a77a6c49-2601-474a-88ac-970e540f9c51
Public Version Date: September 11, 2024
Public Version Number: 1
DI Record Publish Date: September 03, 2024