Accutach Flow Sensor

Basic Information

• Brand Name: Accutach Flow Sensor
• Primary DI: 00850008733048
• Version / Model: 25250
• Catalog Number: 25250
• Company Name: B&B Medical Technologies
• Labeler DUNS: 829743579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-18
• Public Version: 1
• Public Version Date: 2019-07-26
• Public Version Status: New
• Public Device Record Key: c365c2b1-15a0-4002-9628-f4c69ed243e7

Device Description

Pneumotach Adult Flow Sensor, 50 units

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
JAX	Pneumotachometer	Anesthesiology	868.2550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36849	Breathing circuit gas-flow sensor, reusable	A device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850008733048	GS1

Premarket Submissions

Submission Number	Supplement Number
K770061	000