Hydrofera Blue Ready - TSD

GUDID 00854827008004

HYDROFERA, LLC

Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial Wound-nonadherent dressing, permeable, antimicrobial

• Primary Device ID: 00854827008004
• NIH Device Record Key: 9468fd2c-6d3c-453d-9a0a-a94c023004b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrofera Blue Ready - TSD
• Version Model Number: HBRS3535
• Company DUNS: 080660602
• Company Name: HYDROFERA, LLC
• Device Count: 30
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch
• Length: 3.5 Inch
• Width: 3.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854827008004 [Unit of Use]
GS1	00854827008165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130670

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: 2024-01-19
• Device Publish Date: 2024-01-11

Devices Manufactured by HYDROFERA, LLC

• 00854827008004 - Hydrofera Blue Ready - TSD: 2024-01-19
• 00854827008004 - Hydrofera Blue Ready - TSD: 2024-01-19
• 00854827008585 - Hydrofera Blue: 2020-10-22 Hydrofera Blue Classic Comfortcell Interface Antibacterial Foam Dressing
• 10854827008346 - Hydrofera Blue: 2019-12-24 Hydrofera Blue Classic Comfortcell Interface Antibacterial Foam Dressing
• 10854827008353 - Hydrofera Blue: 2019-12-24 Hydrofera Blue Classic Comfortcell Interface Antibacterial Dressing
• 10854827008360 - Hydrofera Blue Ready - Border: 2019-12-24 Hydrofera Blue Ready - Border 4" x 4" Antibacterial Foam Dressing
• 10854827008377 - Hydrofera Blue Ready - Border: 2019-12-24 Hydrofera Blue Ready - Border 5.9" x 5.9" Antibacterial Foam Dressing
• 10854827008384 - Hydrofera Blue Ready - Border: 2019-12-24 Hydrofera Blue Ready - Border 6" x 8" Antibacterial Foam Dressing
• 10854827008391 - Hydrofera Blue Ready - Border: 2019-12-24 Hydrofera Blue Ready - Border 3.8" x 7.5" Antibacterial Foam Dressing