AccessGUDID - DEVICE: Microstream Luer (20884521762050)

GUDID

Device Identifier (DI) Information

Brand Name: Microstream Luer
Version or Model: MLAO
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORIDION MEDICAL 1987 LTD.

Primary DI Number: 20884521762050
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600111512 *Terms of Use

Device Description: Adult Oral-Nasal CO2 Sampling Line with O2 Tubing; Short-term use: Procedural/Emergency

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
36306	Nasal oxygen cannula, carbon-dioxide-sampling	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Meter
Device Size Text, specify: Airflow Volume, less than or equal to 5, Liter/min;

Device Record Status

Public Device Record Key: 8ec55cc1-8f9d-4c17-b91b-0f86da1b4d73
Public Version Date: May 19, 2023
Public Version Number: 4
DI Record Publish Date: January 08, 2020