GranuFlo 0FD2301-3B

GUDID 00840861101542

GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis

Fresenius Medical Care Renal Therapies Group, LLC

Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate
Primary Device ID00840861101542
NIH Device Record Key2fadf609-388d-4e56-90a8-121983bc7f3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGranuFlo
Version Model Number0FD2301-3B
Catalog Number0FD2301-3B
Company DUNS079732391
Company NameFresenius Medical Care Renal Therapies Group, LLC
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx
Phone+1(800)323-5188
Emailxxx@xxx.xxx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.
Special Storage Condition, SpecifyBetween 0 and 0 *This product may be stored and used for up to 14 days from the date it was mixed.

Device Identifiers

Device Issuing AgencyDevice ID
GS100840861101542 [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 Date2015-10-02

On-Brand Devices [GranuFlo]

00840861101603GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
00840861101597GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
00840861101580GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
00840861101573GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
00840861101542GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
00840861101535GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
00840861101528GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
00840861101481GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis
00840861101474GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis

Trademark Results [GranuFlo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GRANUFLO
GRANUFLO
74311503 1848052 Live/Registered
Fresenius USA, Inc.
1992-09-08
GRANUFLO
GRANUFLO
73668541 1530494 Live/Registered
UCB, SOCIETE ANONYME
1987-06-25

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