Circulaire II PEP Accessory Kit

GUDID 00709078000829

with extra reservoir bag

WESTMED, INC.

Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use
Primary Device ID00709078000829
NIH Device Record Key64076455-0fa3-4ef8-8cee-e86ee2f5770d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCirculaire II PEP Accessory Kit
Version Model Number0337
Company DUNS092673953
Company NameWESTMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100709078000829 [Primary]
GS110709078000826 [Package]
Package: [25 Units]
In Commercial Distribution

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-11

On-Brand Devices [Circulaire II PEP Accessory Kit]

00709078000829with extra reservoir bag
007090780007750262 PEP Accessory Kit 0336 Circulaire II Aerosol Drug Delivery System

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