FDA UDI
In Commercial Distribution
🇺🇸 United States
Hydrofera Blue
DI: 20854827008145
·
Model: HBRF4475
·
HYDROFERA, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Hydrofera Blue
- Primary DI
- 20854827008145
- Version / Model
- HBRF4475
- Company Name
- HYDROFERA, LLC
- Labeler DUNS
- 080660602
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-06-01
- Public Version
- 4
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- 127a1291-4f9d-4a24-8bb6-acac14126a01
Device Description
CLASSIC Antibacterial Foam Island Dressing with Moisture-Retentive Film
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47203 | Wound-nonadherent dressing, permeable, antimicrobial | A wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin, and that contains an antimicrobial agent (e.g., silver (Ag), honey). Its pores permit the drainage of exudates from, and application of medication to, the wound. This device may be used with other wound-care products to help heal chronic/infected and postoperative wounds, burns, skin grafts, cuts, or abrasions; it is not a dedicated burn dressing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20854827008145 | GS1 | ||||
| Unit of Use | 10854827008148 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013462 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 4.0 | Inch | |
| Width | 4.75 | Inch |