AccessGUDID - DEVICE: ToxCO (05060246860030)

GUDID

Device Identifier (DI) Information

Brand Name: ToxCO
Version or Model: ToxCO
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TOXCO-USA
Company Name: BEDFONT SCIENTIFIC LIMITED

Primary DI Number: 05060246860030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 293959094 *Terms of Use

Device Description: The ToxCO Breath Carbon Monoxide Monitor is used in the screening of Carbon Monoxide (CO) poisoning and calculation of the Carboxyhaemoglobin (COHb) level. The ToxCO Breath Carbon Monoxide Monitor can be used by healthcare professionals in medical institutions, emergency medical services where Carbon Monoxide exposure is suspected for paediatric, adult, and unconscious patients.

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 [?]
K173238	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a1438018-131d-4061-b72e-8658e5bbbb84
Public Version Date: March 20, 2020
Public Version Number: 1
DI Record Publish Date: March 12, 2020