Hydrofera Blue Ready
GUDID 00854827008721
Hydrofera Blue Ready 4"x5"
HYDROFERA, LLC
Wound-nonadherent dressing, permeable, antimicrobial| Primary Device ID | 00854827008721 |
| NIH Device Record Key | c74541f1-6d89-4123-8db1-c72fff6b5fe5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hydrofera Blue Ready |
| Version Model Number | HBRS4520E |
| 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 | 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 | 00854827008714 [Primary] |
| GS1 | 00854827008721 [Package] Contains: 00854827008714 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" |
Trademark Results [Hydrofera Blue Ready]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYDROFERA BLUE READY 88105068 5761546 Live/Registered |
HYDROFERA, LLC 2018-09-05 |
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