DART-Reach

Basic Information

• Brand Name: DART-Reach
• Primary DI: 00841470103828
• Version / Model: 301-REACH700
• Company Name: ENGINEERED MEDICAL SYSTEMS INC
• Labeler DUNS: 154502934
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-25
• Public Version: 1
• Public Version Date: 2022-04-04
• Public Version Status: New
• Public Device Record Key: 902b6352-0d27-4aec-99ad-96d7a21605f2

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCT	Applicator (Laryngo-Tracheal), Topical Anesthesia	Anesthesiology	868.5170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10226	Atomizer, non-ventilatory	A non-powered, non-ventilatory device intended to provide liquid medication in an aerosolized airborne form for a patient to breathe. It is typically hand-operated. Unlike a nebulizer this devices lacks a baffle, therefore the particle size of the aerosol is not stabilized.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10841470103825	GS1		25	In Commercial Distribution
Primary	00841470103828	GS1

Premarket Submissions

Submission Number	Supplement Number
K070596	000

Device Sizes

Type	Value	Unit	Text
Length	218	Millimeter