Responsive Respiratory, Inc.

Basic Information

• Brand Name: Responsive Respiratory, Inc.
• Primary DI: 00851440007599
• Version / Model: 180-5004
• Company Name: RESPONSIVE RESPIRATORY, INC.
• Labeler DUNS: 129132747
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-12
• Public Version: 1
• Public Version Date: 2023-06-20
• Public Version Status: New
• Public Device Record Key: fa2c2ac2-3aee-4794-acf7-1ede13ec9f6e

Device Description

Liter Meter, 0-2.5 LPM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
BXY	Flowmeter, Calibration, Gas	Anesthesiology	868.2350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31283	Anaesthesia/respiratory gas flowmeter tester	A device designed to determine the accuracy of an anaesthesia/respiratory gas flowmeter, or other respiratory equipment, by serving as a standard of gas flow measurement. Different types use different methods to measure the gas flow rate such as the use of a high-precision calibrated tube, or change in pressure caused by gas flow through an orifice. The device may be calibrated to indicate gas flow rate, e.g., when the outflow is open to the atmosphere or against a specific back pressure. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851440007599	GS1