Diasafe 5008203

GUDID 04039361001391

FILTER, DIASAFE PLUS

Fresenius Medical Care AG & Co. KGaA

Haemodialysis system dialysate pyrogen filter
Primary Device ID04039361001391
NIH Device Record Key72fc770e-4a9f-4dec-8c14-4ba17a1c761d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiasafe
Version Model Number5008201
Catalog Number5008203
Company DUNS324661834
Company NameFresenius Medical Care AG & Co. KGaA
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)227-2572
Emailxxx@xxx.xxx

Device Dimensions

Area/Surface Area2.2 Square meter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104039361001384 [Primary]
GS104039361001391 [Package]
Contains: 04039361001384
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FIPSUBSYSTEM, WATER PURIFICATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-30
Device Publish Date2015-10-23

Devices Manufactured by Fresenius Medical Care AG & Co. KGaA

04039361001117 - Hemoflow™2024-06-12 F40S Hemoflow Dialyzer / High Flux / Polysulfone / 0.7 m2 / Steam / Single Use / 42 mL
04039361001391 - Diasafe2020-03-30FILTER, DIASAFE PLUS
04039361001391 - Diasafe2020-03-30 FILTER, DIASAFE PLUS

Trademark Results [Diasafe]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIASAFE
DIASAFE
75127470 2221928 Live/Registered
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
1996-07-01

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