ManukaPli 44ge

GUDID 05060188822387

MANUKAMED LIMITED PARTNERSHIP

Medical-honey liquid barrier dressing, sterile Medical-honey liquid barrier dressing, sterile Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial Cavity-wound management dressing, antimicrobial

• Primary Device ID: 05060188822387
• NIH Device Record Key: ae4c5e0a-6a88-4918-9a11-1cda39b98805
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ManukaPli 44ge
• Version Model Number: MM0051
• Company DUNS: 594970245
• Company Name: MANUKAMED LIMITED PARTNERSHIP
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060188822387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092689

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: 2019-06-03
• Device Publish Date: 2019-05-24

Devices Manufactured by MANUKAMED LIMITED PARTNERSHIP

• 00854056008004 - First Honey Sterile Honey Ointment (1.0 Oz): 2020-05-22
• 00854056008011 - First Honey Sterile Honey Ointment (0.5 Oz): 2020-05-22
• 00854056008035 - First Honey Manuka Bandages: 2020-05-22 A unit carton of 12 Bandages.
• 00854056008042 - First Honey Manuka Dressings: 2020-05-22 A unit carton of six 3" x4" Manuka Honey coated adhesive island wound dressings
• 00854056008134 - First Honey Sterile Honey Ointment (1.0 Oz): 2020-05-22
• 05060188820055 - MANUKAhd Lite 5 x 5 cm: 2020-05-22
• 05060188820093 - MANUKAhd Lite 10 x 12.5 cm: 2020-05-22
• 05060188820222 - First Honey Manuka Bandages: 2020-05-22 A unit carton of twelve 1"x3" manuka honey coated bandages.