| Primary Device ID | 00854827008004 |
| NIH Device Record Key | 9468fd2c-6d3c-453d-9a0a-a94c023004b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hydrofera Blue Ready - TSD |
| Version Model Number | HBRS3535 |
| Company DUNS | 080660602 |
| Company Name | HYDROFERA, LLC |
| Device Count | 30 |
| 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 |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Length | 3.5 Inch |
| Width | 3.5 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854827008004 [Unit of Use] |
| GS1 | 00854827008165 [Primary] |
| FRO | Dressing, Wound, Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-19 |
| Device Publish Date | 2024-01-11 |
| 00854827008189 - Hydrofera Blue Classic | 2024-12-02 Hydrofera Blue Classic 2"x2" |
| 00854827008202 - Hydrofera Blue Classic | 2024-12-02 Hydrofera Blue Classic 4"x4" |
| 00854827008226 - Hydrofera Blue Classic | 2024-12-02 Hydrofera Blue Classic 4"x5" |
| 00854827008240 - Hydrofera Blue Classic | 2024-12-02 Hydrofera Blue Classic 6"x6" |
| 00854827008257 - Hydrofera Blue Classic | 2024-12-02 Hydrofera Blue Classic Heavy Drainage 4"x4" |
| 00854827008288 - Hydrofera Blue Classic | 2024-12-02 Hydrofera Blue Classic Heavy Drainage 6"x6" |
| 00854827008301 - Hydrofera Blue Classic | 2024-12-02 Hydrofera Blue Classic Ostomy |
| 00854827008455 - Hydrofera Blue Classic | 2024-12-02 Hydrofera Blue Classic ComfortCel 4"x5" |