Hydrofera Blue
GUDID 00854827008585
Hydrofera Blue Classic Comfortcell Interface Antibacterial Foam Dressing
HYDROFERA, LLC
Wound-nonadherent dressing, permeable, antimicrobial| Primary Device ID | 00854827008585 |
| NIH Device Record Key | cfdeda71-f8d1-4ead-a082-af0b1254c041 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hydrofera Blue |
| Version Model Number | HBCC4550 |
| 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
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
| Length | 4 Inch |
| Width | 5 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854827008585 [Unit of Use] |
| GS1 | 00854827008592 [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 | 2020-10-22 |
| Device Publish Date | 2020-10-14 |
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 |
Trademark Results [Hydrofera Blue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYDROFERA BLUE 76680834 3464976 Live/Registered |
HDYROFERA, LLC 2007-08-17 |
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