AccessGUDID - DEVICE: Calibration Gas (05700699621887)

GUDID

Device Identifier (DI) Information

Brand Name: Calibration Gas
Version or Model: 962-188
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 962-188
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699621887
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: TCM4 CAL GAS

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Transcutaneous blood gas monitor, paediatric	A mains electricity (AC-powered) device designed for the continuous, transcutaneous (through the skin) measure of the partial pressure of oxygen (pO2) and the partial pressure of carbon dioxide (pCO2) in a paediatric patient's blood. It includes a special sensor that is typically heated to increase the blood flow and gas diffusion at the point of application on the skin's surface. The gas then diffuses through the membrane of the sensor and is measured by the device; results are digitally displayed and/or printed. This device is especially used to measure and display pO2/pCO2 in infants not under gas anaesthesia.

GMDN Preferred Term Name

GMDN Definition

Transcutaneous blood gas monitor, paediatric

A mains electricity (AC-powered) device designed for the continuous, transcutaneous (through the skin) measure of the partial pressure of oxygen (pO2) and the partial pressure of carbon dioxide (pCO2) in a paediatric patient's blood. It includes a special sensor that is typically heated to increase the blood flow and gas diffusion at the point of application on the skin's surface. The gas then diffuses through the membrane of the sensor and is measured by the device; results are digitally displayed and/or printed. This device is especially used to measure and display pO2/pCO2 in infants not under gas anaesthesia.

FDA Product Code

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Product Code	Product Code Name
LKD	MONITOR, CARBON-DIOXIDE, CUTANEOUS
LPP	Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia
DPZ	Oximeter, ear
KLK	Monitor, oxygen, cutaneous, for infant not under gas anesthesia
DQA	Oximeter

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

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Storage and Handling
Special Storage Condition, Specify: Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment Temperature: between 4 and 30 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 670c3ab9-1ce8-4e1d-962d-a574434ad9bf
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016