Hydrofera Blue Classic

GUDID 00854827008301

Hydrofera Blue Classic Ostomy

HYDROFERA, LLC

Wound-nonadherent dressing, permeable, antimicrobial

• Primary Device ID: 00854827008301
• NIH Device Record Key: 84285428-8506-45de-bf07-f65ec13ccb7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrofera Blue Classic
• Version Model Number: HBRF2650E
• 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

• Outer Diameter: 2.5 Inch
• Outer Diameter: 2.5 Inch
• Outer Diameter: 2.5 Inch
• Outer Diameter: 2.5 Inch
• Outer Diameter: 2.5 Inch
• Outer Diameter: 2.5 Inch
• Outer Diameter: 2.5 Inch
• Outer Diameter: 2.5 Inch
• Outer Diameter: 2.5 Inch
• Outer Diameter: 2.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854827008295 [Primary]
GS1	00854827008301 [Package]; Contains: 00854827008295; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013462

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 Classic]

• 00854827008622: Hydrofera Blue Ready 6"x9mm
• 00854827008608: Hydrofera Blue Classic ComfortCel 6"x6"
• 00854827008455: Hydrofera Blue Classic ComfortCel 4"x5"
• 00854827008301: Hydrofera Blue Classic Ostomy
• 00854827008288: Hydrofera Blue Classic Heavy Drainage 6"x6"
• 00854827008257: Hydrofera Blue Classic Heavy Drainage 4"x4"
• 00854827008240: Hydrofera Blue Classic 6"x6"
• 00854827008226: Hydrofera Blue Classic 4"x5"
• 00854827008202: Hydrofera Blue Classic 4"x4"
• 00854827008189: Hydrofera Blue Classic 2"x2"