Hydrofera Blue Ready - Border

GUDID 10854827008407

Hydrofera Blue Ready - Border 3.8" x 10" Antibacterial Foam Dressing

HYDROFERA, LLC

Wound-nonadherent dressing, permeable, antimicrobial

• Primary Device ID: 10854827008407
• NIH Device Record Key: e1d6ecc5-20b9-4cec-af75-c2f099573b1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrofera Blue Ready - Border
• Version Model Number: HBRB3810
• Company DUNS: 080660602
• Company Name: HYDROFERA, LLC
• Device Count: 10
• 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: 3.8 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854827008400 [Unit of Use]
GS1	10854827008407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190268

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 Ready - Border]

• 10854827008421: Hydrofera Blue Ready - Border 7.9" x 7.5" Antibacterial Foam Dressing
• 10854827008414: Hydrofera Blue Ready - Border 3.8" x 13.5" Antibacterial Foam Dressing
• 10854827008407: Hydrofera Blue Ready - Border 3.8" x 10" Antibacterial Foam Dressing
• 10854827008391: Hydrofera Blue Ready - Border 3.8" x 7.5" Antibacterial Foam Dressing
• 10854827008384: Hydrofera Blue Ready - Border 6" x 8" Antibacterial Foam Dressing
• 10854827008377: Hydrofera Blue Ready - Border 5.9" x 5.9" Antibacterial Foam Dressing
• 10854827008360: Hydrofera Blue Ready - Border 4" x 4" Antibacterial Foam Dressing