FloSense

Basic Information

• Brand Name: FloSense
• Primary DI: B279S298010
• Version / Model: FloSense
• Catalog Number: 29-8010
• Company Name: S D I DIAGNOSTICS INC
• Labeler DUNS: 037690120
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-07-26
• Public Version: 4
• Public Version Date: 2019-08-26
• Public Version Status: Update
• Public Device Record Key: 7a1e7170-6a61-4992-b0c3-9ad69e6a55e6
• Distribution End Date: 2019-07-31

Device Description

Pneumotachometer

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: 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
35282	Pulmonary function analysis system, adult	A device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B279S298011	HIBCC	case	50	Not in Commercial Distribution	2019-07-31
Primary	B279S298010	HIBCC
Unit of Use	S2980101	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K990962	000