Device
The Precision Sampling Set is a single use microfluidic sampling set (nasal cannula). To ensure a valid sampling set is used, when the Precision Sampling Set is connected to the Mo...
Manufacturer
Capnia, INC.
Capnia, INC.
Model: C20206
DI: 00858481006055
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-29
Description
The Precision Sampling Set is a single use microfluidic sampling set (nasal cannula). To ensure a valid sampling set is used, when the Precision Sampling Set is connected to the Monitor, there is an electronic handshake between it and the CoSense Monitor. Note: The CoSense 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:
0251abd5-86ba-4559-b1ef-245cb2f188a5
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:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00858481006062
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
20
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00858481006055
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00858481006055
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00858481006079
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
4
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
00858481006062
Item #3 - Device ID 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