Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie

GUDID M535SLE3011M30985

MEDISYSTEMS CORPORATION

Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set Haemodialysis/haemofiltration system component set
Primary Device IDM535SLE3011M30985
NIH Device Record Key777bc5dd-1b16-4133-b0ac-cf5bb854ec2b
Commercial Distribution Discontinuation2021-09-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameStreamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie
Version Model NumberSLE-3011M3098
Company DUNS061310132
Company NameMEDISYSTEMS CORPORATION
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com
Phone1-866-697-8243
Emailinfo@nxstage.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM535SLE3011M30980 [Primary]
HIBCCM535SLE3011M30985 [Package]
Contains: M535SLE3011M30980
Package: [9 Units]
Discontinued: 2021-09-30
Not in Commercial Distribution

FDA Product Code

KDIDialyzer, High Permeability With Or Without Sealed Dialysate System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-11-18
Device Publish Date2015-09-01

On-Brand Devices [Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie]

M535SLE3011M30985SLE-3011M3098
M535SLE3010M30965SLE-3010M3096
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.