AccessGUDID - DEVICE: MedSource Sampling Cannula (00840155408975)

GUDID

Device Identifier (DI) Information

Brand Name: MedSource Sampling Cannula
Version or Model: MS-35770
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Not Applicable
Company Name: MEDSOURCE INTERNATIONAL LLC

Primary DI Number: 00840155408975
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041674552 *Terms of Use

Device Description: All Purpose Sampling Line with T-Connector

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):	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?
64429	Carbon dioxide breath analyser, home-use	An electrically-powered device intended to be used in a clinical setting and in the home to measure the concentration of exhaled carbon dioxide (CO2) in normal tidal breathing, using a particular method (e.g., infrared spectroscopy, gas chromatography), and to telemetrically send data to a remote server and/or local computer/tablet for viewing results and clinical evaluation by a healthcare professional. It consists of a hand-held sensor unit and might in addition include a replaceable breath sampling chamber and a breathing mouthpiece. It is used to help identify or assess cardio-respiratory conditions (e.g., chronic obstructive pulmonary disease, asthma, chronic heart failure).	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 [?]
K143127	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: 92c4440d-7177-4d5c-a037-8032fd7ed6de
Public Version Date: August 03, 2023
Public Version Number: 4
DI Record Publish Date: June 18, 2021