DriSate DF-111

GUDID 00814963021381

ROCKWELL MEDICAL, INC.

Haemodialysis concentrate Haemodialysis concentrate
Primary Device ID00814963021381
NIH Device Record Keydaba579a-edeb-49fc-a21b-f42f8cc38f6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDriSate
Version Model NumberDF-111
Catalog NumberDF-111
Company DUNS933721433
Company NameROCKWELL MEDICAL, INC.
Device Count1
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814963021381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-27

On-Brand Devices [DriSate]

00814963021404DF-113
00814963021398DF-112
00814963021381DF-111
00814963020698DR-250
00814963020681DR-245
00814963020674DR-230
00814963020667DR-210
00814963020650DR-145
00814963020643DR-130
00814963020636DR-120
00814963020629DF-240
00814963020612DF-220
00814963020605DF-140
00814963020599DF-125
00814963020582DF-120
00814963020575DF-115
00814963020568DC-124
00814963020551DC-117
00814963020544DC-116
00814963020537DC-114
00814963020520DC-110
00814963020513DC-108
00814963020506DC-109
00814963020490DC-103

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.