NA

Basic Information

• Brand Name: NA
• Primary DI: 10620974001697
• Version / Model: SMDIA-1100B
• Catalog Number: SMDIA-1100B
• Company Name: Southmedic Incorporated
• Labeler DUNS: 246848147
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 6
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: e448c97b-eab5-4a47-bb85-b1af636a5969
• Distribution End Date: 2020-12-18

Device Description

MDI Adaptor for use with or without dosage counters -22mm OD/15mm ID x 22mm ID (Flow OD to ID)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAF	NEBULIZER (DIRECT PATIENT INTERFACE)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61166	Inhalation-therapy adaptor, single-use	A connecting device, usually with a small channel or tubing, intended to join a water/saline pack or a noninvasive ventilation respiratory unit to an inhalation therapy device (e.g., humidifier, vibrating mesh nebulizer, oxygen therapy delivery system). It may be used when the connection is compatible (e.g., when the connected devices are of the same manufacture) or when incompatible (e.g., different manufacture). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10620974001697	GS1
Unit of Use	00620974001690	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K101953	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			MDI Adaptor for use with or without dosage counters -22mm OD/15mm ID x 22mm ID (Flow OD to ID)