SMDIA-1100

GUDID 10620974001635

MDI Adaptor for use with or without dosage counters -22 mm OD/ 11mm ID x 22mm ID (Flow OD to ID)

Southmedic Incorporated

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• Primary Device ID: 10620974001635
• NIH Device Record Key: 65dcc843-0271-446b-9287-b454501ca0e9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SMDIA-1100
• Catalog Number: SMDIA-1100
• Company DUNS: 246848147
• Company Name: Southmedic Incorporated
• Device Count: 25
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com
• Phone: +1(705)726-9383
• Email: custserv@southmedic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00620974001638 [Unit of Use]
GS1	10620974001635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101953

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-09-01

Devices Manufactured by Southmedic Incorporated

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• 00620974003106 - Oxy2Pro: 2023-12-11 Oxy2Pro Procedural Plus Mask with Male Luer
• 00620974003120 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Kid
• 00620974003137 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Kid Mask with Microsteam connector
• 00620974003151 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Adult
• 00620974003168 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Adult
• 00620974003175 - Oxy2Mask O2/EtCO2: 2023-12-11 Oxy2Mask O2/EtCO2 Adult