DawnMist

Basic Information

• Brand Name: DawnMist
• Primary DI: 30665973013948
• Version / Model: PC209
• Catalog Number: PC209
• Company Name: Dukal LLC
• Labeler DUNS: 791014871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 3
• Public Version Date: 2024-01-09
• Public Version Status: Update
• Public Device Record Key: b44719f7-d5a0-45c8-8cc6-901815ffe89b

Device Description

Non-Latex Tourniquet, 1"x18", Blue

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
GAX	TOURNIQUET, NONPNEUMATIC	General, Plastic Surgery	878.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67046	Emergency tourniquet, manual, single-use	A device in the form of a band or strap intended to be wrapped and manually tightened around a patient's limb (arm or leg) to control/stop life-threatening bleeding (e.g., in a military setting and/or high-risk work environment); it may additionally be used in non-life-threatening injuries. It typically includes an adherent layer (e.g., Velcro) and/or a buckle mechanism for fastening/locking that allows adjustments to the degree of tightness. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00665973013947	GS1
Primary	30665973013948	GS1

Customer Contacts

• Phone: [phone] ext. 172
• Email: [email protected]