AccessGUDID - DEVICE: Micro Medical (54250892980015)

GUDID

Device Identifier (DI) Information

Brand Name: Micro Medical
Version or Model: 36-MC02-STK
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 36-MC02-STK
Company Name: CAREFUSION U.K. 232 LIMITED

Primary DI Number: 54250892980015
Issuing Agency: GS1
Commercial Distribution End Date: May 22, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 291555621 *Terms of Use

Device Description: MicroCO

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?
35467	Carbon monoxide breath analyser	An electronic device intended to be used in a clinical setting to measure the concentration of carbon monoxide (CO) in a gas-mixture sample, exhaled by a patient, using a particular method (e.g., electrochemical, infrared spectroscopy, gas chromatography). It may be used to aid in determining the patient's ventilatory status (typically the lung diffusing capacity), or for determining exhaled CO levels (e.g., during jaundice screening in newborns, or in smoking cessation programs); it may also have the capacity to measure the concentration of CO in the atmosphere.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCJ	Analyzer, Gas, Carbon-Monoxide, 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 30 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cdd3ef4c-7845-44c4-bb9e-5bc151af1d06
Public Version Date: May 23, 2019
Public Version Number: 3
DI Record Publish Date: July 29, 2016