Green Guard Cold Spray 3005

GUDID 50347682030051

A non-sterile liquid in a spray container intended for localized application to the body surface to provide a cooling effect for underlying muscles/joints to reduce pain and swelling.

Greenguard

Cold/cool therapy spray

• Primary Device ID: 50347682030051
• NIH Device Record Key: 2700f674-df5d-4b00-b43b-334d9fd1e112
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Green Guard Cold Spray
• Version Model Number: 3005
• Catalog Number: 3005
• Company DUNS: 176528040
• Company Name: Greenguard
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-869-6970
• Email: cs@greenguard.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 C and keep away from fire or flame,

Device Identifiers

Device Issuing Agency	Device ID
GS1	00347682030056 [Primary]
GS1	50347682030051 [Package]; Contains: 00347682030056; Package: master case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033720

FDA Product Code

• MLY: Refrigerant, Topical (Vapocoolant)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-04
• Device Publish Date: 2019-06-26

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• 50347682625332 - Green Guard Waterproof tape 1/2" x 5 yards: 2019-10-23 A non-sterile, long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a mate
• 50347682625448 - Green Guard Waterproof Tape 1" x 5 yards: 2019-10-23 A non-sterile, long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a mate
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