Pure Air Mini Nebulizer

GUDID 10850632007550

Mini Compressor Nebulizer. Portable and lightweight . AC powered. Child and Adult masks included

HOME AIDE DIAGNOSTICS, INC.

Nebulizing system, non-heated
Primary Device ID10850632007550
NIH Device Record Keybe97f420-c6cc-4fe9-a0c2-b915e348f2ae
Commercial Distribution StatusIn Commercial Distribution
Brand NamePure Air Mini Nebulizer
Version Model NumberMCN-S600A
Company DUNS783518983
Company NameHOME AIDE DIAGNOSTICS, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us
Phone1-800-915-0116
Emailinfo@homeaide.us

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850632007553 [Primary]
GS110850632007550 [Package]
Contains: 00850632007553
Package: Outer Carton [32 Units]
In Commercial Distribution

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-01
Device Publish Date2020-03-24

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