HMB32

GUDID 08051411600350

dialysis solution,ml 500+4500

HAEMOPHARM BIOFLUIDS SRL

Haemodialysis dialysate solution
Primary Device ID08051411600350
NIH Device Record Keyf390b616-25a8-4a03-90cf-d576503fa617
Commercial Distribution StatusIn Commercial Distribution
Brand NameHMB32
Version Model NumberMD088
Company DUNS630034952
Company NameHAEMOPHARM BIOFLUIDS SRL
Device Count2
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter
Total Volume5000 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS108051411600350 [Unit of Use]
GS138051411600351 [Primary]

FDA Product Code

KPODIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-12
Device Publish Date2021-07-03

On-Brand Devices [HMB32]

10884521807990haemofiltration and dialysis solution,ml 500+1500 each
08051411600350dialysis solution,ml 500+4500

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