AccessGUDID - DEVICE: Respiratory Mechanics Flow Sensor

GUDID

Device Identifier (DI) Information

Brand Name: Respiratory Mechanics Flow Sensor – Adult/Pediatric
Version or Model: 5957134
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DRAEGER MEDICAL SYSTEMS, INC.

Primary DI Number: 04049098007740
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788289952 *Terms of Use

Device Description: No description.

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":	No
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?
46821	Carbon dioxide cuvette, single-use	A non-electrical device intended to be used with a mainstream carbon dioxide (CO2) sensor for the determination of CO2 concentration in gases expired from a patient. It is designed as a small, plastic, open-ended vessel with a clear optic window (cuvette) for the acceptance of an infrared sensor [not included] that is slotted over the outside of the window section; some types may additionally feature an adaptor for the acceptance of a gas flow sensor. It typically has connector ports that enable it to be connected into a breathing system (e.g., an anaesthesia or critical care ventilation system). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXP	Transducer, Gas Flow

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: cfc58d06-c895-4c93-8c3f-1feb54a63840
Public Version Date: August 07, 2024
Public Version Number: 4
DI Record Publish Date: November 02, 2015