ALLSTART

Basic Information

• Brand Name: ALLSTART
• Primary DI: 06972813300025
• Version / Model: TC011106
• Company Name: Hangzhou Wellbeing Technology Co.,Ltd.
• Labeler DUNS: 414010999
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-08
• Public Version: 1
• Public Version Date: 2022-11-16
• Public Version Status: New
• Public Device Record Key: d67288c9-7101-4710-8beb-02da61617c49

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	890.5700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59251	Cold compression therapy cervical spine collar	A prefabricated (non-customized) wearable device intended to facilitate, through cooling and compression, the treatment of a variety of conditions resulting from injury/surgery to the neck region (e.g., inflammation, stiffness, whiplash). It consists of a cover/wrap intended to be frozen then strapped and fastened around the neck to support the entire neck, upper shoulders, and spine region. It is typically multi-layered with a skin contact surface intended to minimize cold-burn, a gel component (designed to maintain low temperatures), and stretchable outer surface. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06972813300025	GS1