Pro Comfort Inhaler Space Chamber w/ INFANT mask 7560

GUDID 10850632007567

Inhaler chamber for use with inhaler (not included) for infants. Includes infant mask.

HOME AIDE DIAGNOSTICS, INC.

Medicine chamber spacer, reusable
Primary Device ID10850632007567
NIH Device Record Key58a8601d-92d8-4c73-ab60-d27c8919af2b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePro Comfort Inhaler Space Chamber w/ INFANT mask
Version Model Number2.4.7
Catalog Number7560
Company DUNS783518983
Company NameHOME AIDE DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us

Device Identifiers

Device Issuing AgencyDevice ID
GS100850632007560 [Primary]
GS110850632007567 [Package]
Contains: 00850632007560
Package: Carton [50 Units]
In Commercial Distribution

FDA Product Code

DYNMouthpiece, Saliva Ejector

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-31
Device Publish Date2020-03-23

Devices Manufactured by HOME AIDE DIAGNOSTICS, INC.

10850058864102 - True-Comfort Pen Needles 4mm2024-07-05 100ct box. 32G x 5/32 (4mm) Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile ne
10850027494224 - Easy Talk/Plus II Glucose Test Strips2024-06-24 Box of 50 Glucose Strips compatible with Easy Talk Glucose Monitor and Easy Plus II Glucose Monitor
10850027494309 - Easy Talk/PlusII Control Solution LOW2024-06-24 Easy Talk/PlusII Control Solution LOW
10850027494316 - Easy Talk/PlusII Control Solution HIGH2024-06-24 Easy Talk/PlusII Control Solution HIGH
10850027494330 - True Comfort Back Compression Wrap2024-06-24 True Comfort Back Compression Wrap
10850027494613 - Easy Comfort 1L Sharps Container {1.06 Quarts}2024-06-24 1L Sharps Container {1.06 Quarts}
10850058864089 - Easy Comfort 3L Sharps Container {3.17 Quarts}2024-06-24 3L Sharps Container {3.17 Quarts}
10850058864096 - Easy Comfort 5L Sharps Container {5.28 Quarts}2024-06-24 5L Sharps Container {5.28 Quarts}

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.