SMDIA-1300

GUDID 10620974001673

MDI Adaptor for use with or without dosage counters - 15mm OD x 15mm ID (Flow OD to ID)

Southmedic Incorporated

Inhalation-therapy adaptor, single-use
Primary Device ID10620974001673
NIH Device Record Key732c00ed-57fe-48b1-a292-53e609b3e1c6
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSMDIA-1300
Catalog NumberSMDIA-1300
Company DUNS246848147
Company NameSouthmedic Incorporated
Device Count25
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100620974001676 [Unit of Use]
GS110620974001673 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
Public Version Date2022-06-10
Device Publish Date2016-09-01

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