AccessGUDID - DEVICE: Flow sensor (04036616001816)

GUDID

Device Identifier (DI) Information

Brand Name: Flow sensor
Version or Model: SpiroQuant H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07-00-0001
Company Name: Honeywell Healthcare Solutions GmbH

Primary DI Number: 04036616001816
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 330943838 *Terms of Use

Device Description: Flow sensor SpiroQuant H

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":	No
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?
42549	Anaesthesia gas flowmeter	A device intended to be used to measure and regulate the flow of medical gases [e.g., oxygen (O2), nitrous oxide (N2O), or air) from a gas supply to a patient during anaesthesia. The gases are usually mixed to the desired ratio by the operator using separate flowmeters for each gas; the mixed gases are delivered to the patient via a breathing circuit, but may be delivered singularly if desired. This device is typically mounted onto an anaesthesia unit, but may also be used independently (e.g., in a research laboratory setting).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BYR	Transducer, Gas Pressure, Differential

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
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Humidity: between 0 and 99 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 105 Millimeter
Length: 155 Millimeter
Width: 210 Millimeter

Device Record Status

Public Device Record Key: 60f7e0f5-cd9c-425a-93e4-1760859d3f81
Public Version Date: August 01, 2024
Public Version Number: 3
DI Record Publish Date: September 22, 2016