Hydrofera Blue Ready

GUDID 00854827008745

Hydrofera Blue Ready 8"x8"

HYDROFERA, LLC

Wound-nonadherent dressing, permeable, antimicrobial

• Primary Device ID: 00854827008745
• NIH Device Record Key: 095dd390-6436-4840-b106-9a4a7ff39dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrofera Blue Ready
• Version Model Number: HBRS8820E
• Company DUNS: 080660602
• Company Name: HYDROFERA, LLC
• 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: 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: 8 Inch
• Width: 8 Inch
• Length: 8 Inch
• Width: 8 Inch
• Length: 8 Inch
• Width: 8 Inch
• Length: 8 Inch
• Width: 8 Inch
• Length: 8 Inch
• Width: 8 Inch
• Length: 8 Inch
• Width: 8 Inch
• Length: 8 Inch
• Width: 8 Inch
• Length: 8 Inch
• Width: 8 Inch
• Length: 8 Inch
• Width: 8 Inch
• Length: 8 Inch
• Width: 8 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854827008738 [Primary]
GS1	00854827008745 [Package]; Contains: 00854827008738; Package: Box [10 Units]; In Commercial Distribution

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: 2024-12-02
• Device Publish Date: 2024-11-22

On-Brand Devices [Hydrofera Blue Ready]

• 00854827008820: Hydrofera Blue Ready TSD 3.5"x3.5"
• 00854827008745: Hydrofera Blue Ready 8"x8"
• 00854827008721: Hydrofera Blue Ready 4"x5"
• 00854827008707: Hydrofera Blue Ready 2.5"x2.5"