ColdSPOT

Basic Information

• Brand Name: ColdSPOT
• Primary DI: 00815137021084
• Version / Model: 502
• Company Name: Beekley Corporation
• Labeler DUNS: 001157841
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 34
• Record Status: Published
• Publish Date: 2019-07-22
• Public Version: 1
• Public Version Date: 2019-07-30
• Public Version Status: New
• Public Device Record Key: 70a5ec5f-3991-49ec-b4d2-c303a93d1f76

Device Description

Cold Therapy Packs, 2.0x3.0" gel pack, with Florals

Device Characteristics

• Single Use: Yes
• 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: 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
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	890.5710	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40555	Hot/cold therapy pack, single-use	A non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel, peat) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20815137021088	GS1		2	In Commercial Distribution
Primary	00815137021084	GS1
Unit of Use	10815137021081	GS1