FDA.reportPublic FDA data

Hydrofera Blue

Primary DI
10854827008391
Brand
Hydrofera Blue
Company
HYDROFERA, LLC
Model
HBRB3875
Device description
"Hydrofera Blue Ready - Border - 3.8"" x 7.5"""
Published
2019-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190268000Hydrofera Blue READY - BorderHydrofera, LLC2019-11-06FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854827008391PrimaryGS10
00854827008394Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085482700839110854827008391
00854827008394008548270083948548270083940854827008394

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, antimicrobialA sterile 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7.5Inch
Width3.8Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080660602
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854827008165Hydrofera BlueHBRS35352024-01-11
00854827008172Hydrofera BlueHB2214E2024-11-22
00854827008196Hydrofera BlueHB4414E2024-11-22
00854827008219Hydrofera BlueHB4514E2024-11-22
00854827008233Hydrofera BlueHB6614E2024-11-22
00854827008271Hydrofera BlueHBHD6675E2024-11-22
00854827008295Hydrofera BlueHBRF2650E2024-11-22
00854827008318Hydrofera BlueHBCC4550E2024-11-22
00854827008462Hydrofera BlueHBCC6675E2024-11-22
00854827008592Hydrofera BlueHBCC45502020-10-14
00854827008615Hydrofera BlueHBT0906E2024-11-22
00854827008639Hydrofera BlueHBRB4040E2024-11-22
00854827008653Hydrofera BlueHBRB5959E2024-11-22
00854827008677Hydrofera BlueHBRB6080E2024-11-22
00854827008691Hydrofera BlueHBRS2520E2024-11-22
00854827008714Hydrofera BlueHBRS4520E2024-11-22
00854827008738Hydrofera BlueHBRS8820E2024-11-22
00854827008752Hydrofera BlueHBRT2525E2024-11-22
00854827008776Hydrofera BlueHBRT4050E2024-11-22
00854827008790Hydrofera BlueHBRT8080E2024-11-22

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