FDA.reportPublic FDA data

Hydrofera Blue Classic

Primary DI
00854827008288
Brand
Hydrofera Blue Classic
Company
HYDROFERA, LLC
Model
HBHD6675E
Device description
Hydrofera Blue Classic Heavy Drainage 6"x6"
Published
2024-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K013462000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013462000HYDROFERA BACTERIOSTATIC WOUND DRESSINGHydrofera, LLC2002-01-11FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854827008288PackageGS15In Commercial Distribution
00854827008271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854827008288008548270082888548270082880854827008288
00854827008271008548270082718548270082710854827008271

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, antimicrobialA 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
Length6Inch
Width6Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080660602
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
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00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08
00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990178Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
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00850067990802Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990895Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
10884389161562MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-06
00361470000175Amerigel Saline Wound WashAmerx Health Care Corp.FRO2026-06-22
00050428280669CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
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