Hydrofera Blue Ready - TSD

GUDID 00854827008004

HYDROFERA, LLC

Wound-nonadherent dressing, permeable, antimicrobial
Primary Device ID00854827008004
NIH Device Record Key9468fd2c-6d3c-453d-9a0a-a94c023004b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameHydrofera Blue Ready - TSD
Version Model NumberHBRS3535
Company DUNS080660602
Company NameHYDROFERA, LLC
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch
Length3.5 Inch
Width3.5 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100854827008004 [Unit of Use]
GS100854827008165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-19
Device Publish Date2024-01-11

Devices Manufactured by HYDROFERA, LLC

00854827008004 - Hydrofera Blue Ready - TSD2024-01-19
00854827008004 - Hydrofera Blue Ready - TSD2024-01-19
00854827008585 - Hydrofera Blue2020-10-22 Hydrofera Blue Classic Comfortcell Interface Antibacterial Foam Dressing
10854827008346 - Hydrofera Blue2019-12-24 Hydrofera Blue Classic Comfortcell Interface Antibacterial Foam Dressing
10854827008353 - Hydrofera Blue2019-12-24 Hydrofera Blue Classic Comfortcell Interface Antibacterial Dressing
10854827008360 - Hydrofera Blue Ready - Border2019-12-24 Hydrofera Blue Ready - Border 4" x 4" Antibacterial Foam Dressing
10854827008377 - Hydrofera Blue Ready - Border2019-12-24 Hydrofera Blue Ready - Border 5.9" x 5.9" Antibacterial Foam Dressing
10854827008384 - Hydrofera Blue Ready - Border2019-12-24 Hydrofera Blue Ready - Border 6" x 8" Antibacterial Foam Dressing
10854827008391 - Hydrofera Blue Ready - Border2019-12-24 Hydrofera Blue Ready - Border 3.8" x 7.5" Antibacterial Foam Dressing

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