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 ID: 10620974001673
• NIH Device Record Key: 732c00ed-57fe-48b1-a292-53e609b3e1c6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SMDIA-1300
• Catalog Number: SMDIA-1300
• 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	00620974001676 [Unit of Use]
GS1	10620974001673 [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

• 00620974003694 - Southmedic Instrument Cleaning Brushes: 2025-01-23 Brush-Jar Nylon 13”
• 00620974003700 - Southmedic Instrument Cleaning Brushes: 2025-01-23 Brush-Toothbrush Style, 7” Nylon
• 00620974003717 - Southmedic Instrument Cleaning Brushes: 2025-01-23 Brush-Toothbrush Style, 7” SS
• 00620974003724 - Southmedic Instrument Cleaning Brushes: 2025-01-23 Twisted Wire Brush 16" 5mm
• 00620974003731 - Southmedic Instrument Cleaning Brushes: 2025-01-23 Twisted Wire Brush 16" 7mm
• 00620974003748 - Southmedic Instrument Cleaning Brushes: 2025-01-23 Twisted Wire Brush 16" 10mm
• 00620974003755 - Southmedic Instrument Cleaning Brushes: 2025-01-23 Twisted Wire Brush 16" 12mm
• 00620974003762 - Southmedic Instrument Cleaning Brushes: 2025-01-23 Twisted Wire Brush 12" 2mm