AccessGUDID - DEVICE: Calibration Gas 2 (05700699620965)

GUDID

Device Identifier (DI) Information

Brand Name: Calibration Gas 2
Version or Model: 962-096
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 962-096
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699620965
Issuing Agency: GS1
Commercial Distribution End Date: May 02, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: Calibration Gas 2 standard 1 Litre, 10% CO2, balance: N2

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?
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
KLK	Monitor, oxygen, cutaneous, for infant not under gas anesthesia
DQA	Oximeter
LKD	MONITOR, CARBON-DIOXIDE, CUTANEOUS
LPP	Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia

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 Temperature: between 4 and 30 Degrees Celsius
Special Storage Condition, Specify: To be protected from light or heat

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e88df630-9f17-4b1d-a7a0-4a8b776fd13a
Public Version Date: June 20, 2024
Public Version Number: 4
DI Record Publish Date: September 01, 2016