FDA.reportPublic FDA data

Hydrofera Blue

Primary DI
20854827008121
Brand
Hydrofera Blue
Company
HYDROFERA, LLC
Model
HBRF2650
Device description
Hydrofera Blue Classic Antibacterial Foam Ostomy Dressing
Published
2018-06-01
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
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
20854827008121PrimaryGS10
10854827008124Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085482700812120854827008121
1085482700812410854827008124

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
Outer Diameter2.5Inch

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612553000163VERISHARTMANN USA, INC.FRO2026-10-01
00612553000170VERISHARTMANN USA, INC.FRO2026-10-01
00612553000187VERISHARTMANN USA, INC.FRO2026-10-01
00612553000194VERISHARTMANN USA, INC.FRO2026-10-01
00194346726707equateWAL-MART STORES, INC.FRO2026-09-30
00194346726714equateWAL-MART STORES, INC.FRO2026-09-30
10885380214714CurityCardinal Health 200, LLCFRO2026-09-30
10885380214738CurityCardinal Health 200, LLCFRO2026-09-30
00810226440944ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440951ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440968ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442542ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442559ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442566ViveCareVIVE HEALTH LLCFRO2026-09-29
00810178885329Vive CareVIVE HEALTH LLCFRO2026-09-28
10885380214707CurityCardinal Health 200, LLCFRO2026-09-28
10885380214721CurityCardinal Health 200, LLCFRO2026-09-28
10885380214745CurityCardinal Health 200, LLCFRO2026-09-28
10885380214752CurityCardinal Health 200, LLCFRO2026-09-28
10885380214769CurityCardinal Health 200, LLCFRO2026-09-28
10885380214776CurityCardinal Health 200, LLCFRO2026-09-28
10885380214783CurityCardinal Health 200, LLCFRO2026-09-28
10885380214790CurityCardinal Health 200, LLCFRO2026-09-28
10885380214806CurityCardinal Health 200, LLCFRO2026-09-28
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26