AccessGUDID - DEVICE: CapnoLine / Microstream (20884838071241)

GUDID

Device Identifier (DI) Information

Brand Name: CapnoLine / Microstream
Version or Model: Trade Compliant:CapnoLine H O2 Adult
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 989803183071
Company Name: Philips Medical Systems Hsg

Primary DI Number: 20884838071241
Issuing Agency: GS1
Commercial Distribution End Date: November 01, 2024
Device Count: 25
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: Made In Israel: CapnoLine H O2 Adult

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
36306	Nasal oxygen cannula, carbon-dioxide-sampling	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCK	ANALYZER, GAS, CARBON-DIOXIDE, 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 Temperature: between -20 and 55 Degrees Celsius
Storage Environment Temperature: between -4 and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 57 and 106 KiloPascal
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: af05c2b0-5486-46f0-9cef-cde20d89a4a5
Public Version Date: November 22, 2024
Public Version Number: 8
DI Record Publish Date: April 19, 2018