Flow sensor

Basic Information

• Brand Name: Flow sensor
• Primary DI: 04036616005852
• Version / Model: SpiroQuant H
• Catalog Number: 07-00-0005
• Company Name: EnviteC-Wismar GmbH
• Labeler DUNS: 330943838
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7d0ed05d-315b-4cee-9369-3fa0b241fcf4

Device Description

Flow sensor SpiroQuant H

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	04036616005852	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Height	130	Millimeter
Length	200	Millimeter
Width	200	Millimeter

Storage Conditions

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