BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Flow sensor

DI: 04036616010191 · Model: SpiroQuant H 3m · Honeywell Healthcare Solutions GmbH

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Flow sensor
Primary DI: 04036616010191
Version / Model: SpiroQuant H 3m
Catalog Number: 1000554
Company Name: Honeywell Healthcare Solutions GmbH
Labeler DUNS: 330943838
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-22
Public Version: 3
Public Version Date: 2024-08-01
Public Version Status: Update
Public Device Record Key: 4c9e534e-1b86-460a-9768-6342ee118da5

Device Description

Flow sensor SpiroQuant H 3m

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: MR Unsafe
Direct Marking Exempt: Yes
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYR	Transducer, Gas Pressure, Differential	Anesthesiology	868.2875	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04036616010191	GS1

Device Sizes

Type	Value	Unit	Text
Length	200	Millimeter
Width	150	Millimeter

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 0 – 50 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: -20 – 70 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 0 – 99 Percent (%) Relative Humidity