Device
This is the interchangeable Sensor Module which is inserted into the ETCO Monitor, the CO Sensor Module is replaceable. It has an expiration date. Note: The monitor is a reusable e...
Manufacturer
Capnia, INC.
Capnia, INC.
Model: C20302
DI: 00858481006024
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-29
Description
This is the interchangeable Sensor Module which is inserted into the ETCO Monitor, the CO Sensor Module is replaceable. It has an expiration date. Note: The monitor is a reusable electrical medical device with integrated software used in conjunction with a precision sampling set to collect a breath sample from the patient and measure the end tidal carbon monoxide in exhaled breath. The device is non-sterile. No reprocessing is required between uses.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
a3da3b0a-3705-44f1-9c11-583dc8d10041
Distribution Status:
In Commercial Distribution
DUNS Number:
080371374
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00858481006024
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35467
Name: Carbon monoxide breath analyser
Definition:
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.
FDA Product Codes
CCJ
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Premarket Submissions
Item #1 - Submission Number:
K121768
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K130036
Item #2 - Supplement Number:
000
Item #3 - Submission Number:
K151107
Item #3 - Supplement Number:
000