Circulaire II Aerosol Drug Delivery System

GUDID 10709078000697

Nebulizing system delivery set, single-use

Primary Device ID	10709078000697
NIH Device Record Key	c5b30dfc-8241-4f9a-8fcb-49b9b56ec357
Commercial Distribution Status	In Commercial Distribution
Brand Name	Circulaire II Aerosol Drug Delivery System
Version Model Number	0295
Company DUNS	092673953
Company Name	WESTMED, INC.
Device Count	1
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	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00709078000690 [Primary]
GS1	10709078000697 [Package] Contains: 00709078000690 Package: [25 Units] In Commercial Distribution

CAF	Nebulizer (Direct Patient Interface)

Steralize Prior To Use	false
Device Is Sterile	false

10709078000796	w/ Comfort Soft Plus adult non-vented mask, MiniHeart Hi-Flo, and B/V filter
10709078000789	with Comfort Soft Plus adult non-vented mask, mouthpiece, B/V filter
10709078000734	With extra reservoir bag, with B/V filter, 7' tubing w/threaded nut
10709078000727	with extra reservoir bag, with B/V filter
00709078000706	with VixOne,, nose clip, mouthpiece, adult non-vented mask
10709078000697	with extra reservoir bag, violet