AccessGUDID - DEVICE: LOWENSTEIN MEDICAL (00819601022706)

GUDID

Device Identifier (DI) Information

Brand Name: LOWENSTEIN MEDICAL
Version or Model: ANESTHESIA CALIBRATION GAS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z04OX45MUD0001
Company Name: AIRGAS USA LLC

Primary DI Number: 00819601022706
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831996595 *Terms of Use

Device Description: Description: 4% DES, 6% CO2, 45% N2O/O2 Cylinder: UD; Valve: CGA 165; For calibration of medical analyzers in accordance with manufacturer's instructions.

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):	No
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?
65331	Calibration gas/non-refillable cylinder	A gas or custom mix of gases (e.g., CO2, O2, N2) in a dedicated, cylindrical container intended to calibrate a medical device (e.g., anaesthesia unit, blood gas analyte, patient monitor) to verify that it measures, displays and/or supplies the proper gas type, concentration and/or quantity; it may in addition be used for testing a patient’s pulmonary function. This device is reusable until the contents of the container are exhausted.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXK	Gas, Calibration (Specified Concentration)

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: less than 52 Degrees Celsius
Handling Environment Temperature: more than 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 84 Liter
Pressure: 56 Pound per Square Inch

Device Record Status

Public Device Record Key: 979ffef3-4aa8-476a-8193-f4a660aab6d7
Public Version Date: August 17, 2021
Public Version Number: 1
DI Record Publish Date: August 09, 2021