CVS Health™ 405427

GUDID 00050428547533

Manuka Honey Spot Bandages Infused with Natural Medical-Grade Honey

WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Wound-nonadherent dressing, permeable, antimicrobial

• Primary Device ID: 00050428547533
• NIH Device Record Key: 2026a810-4051-44af-a456-619b2ad714fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CVS Health™
• Version Model Number: 405427
• Catalog Number: 405427
• Company DUNS: 062312574
• Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
• Device Count: 12
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Length: 22 Millimeter
• Width: 22 Millimeter
• Device Size Text, specify: 0
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• Width: 22 Millimeter
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• Width: 22 Millimeter
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• Width: 22 Millimeter
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• Width: 22 Millimeter
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• Width: 22 Millimeter
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• Width: 22 Millimeter
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• Width: 22 Millimeter
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• Width: 22 Millimeter
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• Width: 22 Millimeter
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• Width: 22 Millimeter
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• Width: 22 Millimeter
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• Width: 22 Millimeter
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• Width: 22 Millimeter
• Device Size Text, specify: 0
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• Width: 22 Millimeter
• Device Size Text, specify: 0
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• Width: 22 Millimeter
• Device Size Text, specify: 0
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• Width: 22 Millimeter
• Device Size Text, specify: 0
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• Width: 22 Millimeter
• Device Size Text, specify: 0
• Length: 22 Millimeter
• Width: 22 Millimeter
• Device Size Text, specify: 0
• Length: 22 Millimeter
• Width: 22 Millimeter
• Device Size Text, specify: 0
• Length: 22 Millimeter
• Width: 22 Millimeter
• Device Size Text, specify: 0
• Length: 22 Millimeter
• Width: 22 Millimeter
• Device Size Text, specify: 0
• Length: 22 Millimeter
• Width: 22 Millimeter
• Device Size Text, specify: 0
• Length: 22 Millimeter
• Width: 22 Millimeter
• Device Size Text, specify: 0
• Length: 22 Millimeter
• Width: 22 Millimeter
• Device Size Text, specify: 0
• Length: 22 Millimeter
• Width: 22 Millimeter
• Device Size Text, specify: 0
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• Width: 22 Millimeter
• Device Size Text, specify: 0
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• Width: 22 Millimeter
• Device Size Text, specify: 0
• Length: 22 Millimeter
• Width: 22 Millimeter
• Device Size Text, specify: 0
• Length: 22 Millimeter
• Width: 22 Millimeter
• Device Size Text, specify: 0
• Length: 22 Millimeter
• Width: 22 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Sterility Guaranteed unless individual wrapper has been opened or damaged; Store at Room Temperature; Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00050428547533 [Primary]
GS1	00504285475336 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081584

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-03
• Device Publish Date: 2022-09-24

On-Brand Devices [CVS Health™]

• 00050428547533: Manuka Honey Spot Bandages Infused with Natural Medical-Grade Honey
• 00050428506530: Waterproof Hydrogel Burn Pads Instant Cooling Relief
• 00050428287071: Zinc Wound Wash First Aid Cleanser