Flosense II 29-8040-100

GUDID B279S298040100

Breathing mouthpiece, single-use

Primary Device ID	B279S298040100
NIH Device Record Key	1a08049e-a1ef-48cf-802e-220287a86b0c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Flosense II
Version Model Number	II
Catalog Number	29-8040-100
Company DUNS	037690120
Company Name	S D I DIAGNOSTICS INC
Device Count	100
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B279S298040100 [Primary]
HIBCC	S2980401002 [Unit of Use]

BZG	Spirometer, Diagnostic

Steralize Prior To Use	false
Device Is Sterile	false