Hydrofera Blue

GUDID 10854827008346

Hydrofera Blue Classic Comfortcell Interface Antibacterial Foam Dressing

HYDROFERA, LLC

Wound-nonadherent dressing, permeable, antimicrobial

• Primary Device ID: 10854827008346
• NIH Device Record Key: 8e7b860f-7fba-4bd7-87ce-1180a3180afe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrofera Blue
• Version Model Number: HBCC4450
• Company DUNS: 080660602
• Company Name: HYDROFERA, LLC
• Device Count: 5
• 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

• Width: 4 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854827008349 [Unit of Use]
GS1	10854827008346 [Primary]

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: 2019-12-24
• Device Publish Date: 2019-12-16

On-Brand Devices [Hydrofera Blue]

• 20854827008329: READY Antibacterial Foam Dressing
• 20854827008152: CLASSIC Antibacterial Foam Tunneling Dressing
• 20854827008145: CLASSIC Antibacterial Foam Island Dressing with Moisture-Retentive Film
• 20854827008138: CLASSIC Antibacterial Foam Dressing with Moisture -Retentive Film
• 20854827008121: CLASSIC Antibacterial Foam Ostomy Dressing
• 20854827008114: CLASSIC Antibacterial Foam Dressing with Moisture-Retentive Film
• 20854827008107: CLASSIC HEAVY DRAINAGE Antibacterial Foam Dressing
• 20854827008091: CLASSIC HEAVY DRAINAGE Antibacterial Foam Dressing
• 20854827008084: CLASSIC Antibacterial Foam Dressing
• 20854827008077: CLASSIC Antibacterial Foam Dressing
• 20854827008060: CLASSIC Antibacterial Foam Dressing
• 20854827008053: READY-Transfer Antibacterial Foam Dressing
• 20854827008046: READY-Transfer Antibacterial Foam Dressing
• 20854827008039: READY-Transfer Antibacterial Foam Dressing
• 20854827008022: READY Antibacterial Foam Dressing
• 20854827008015: READY Antibacterial Foam Dressing
• 10854827008353: Hydrofera Blue Classic Comfortcell Interface Antibacterial Dressing
• 10854827008346: Hydrofera Blue Classic Comfortcell Interface Antibacterial Foam Dressing
• 00854827008585: Hydrofera Blue Classic Comfortcell Interface Antibacterial Foam Dressing