AccessGUDID - DEVICE: CapnoLine / Microstream (20884838071203)

GUDID

Device Identifier (DI) Information

Brand Name: CapnoLine / Microstream
Version or Model: Trade Compliant:Smart CapnoLine O2 Adult
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 989803182961
Company Name: Philips Medical Systems Hsg

Primary DI Number: 20884838071203
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: Smart Capnoline O2 Adult

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":	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: 3d158eb3-056c-4fe5-ad02-c6aea3c846fd
Public Version Date: November 22, 2024
Public Version Number: 8
DI Record Publish Date: February 20, 2017