Medisystems Hemodialysis Blood Tubing Sets

GUDID M535B36605M67925

MEDISYSTEMS CORPORATION

Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use
Primary Device IDM535B36605M67925
NIH Device Record Key3ea93c52-a50d-4200-9b54-a2f5b674812e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedisystems Hemodialysis Blood Tubing Sets
Version Model NumberB3-6605M6792
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

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from moisture, freezing and excessive heat
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM535B36605M67920 [Primary]
HIBCCM535B36605M67925 [Package]
Contains: M535B36605M67920
Package: [12 Units]
In Commercial Distribution

FDA Product Code

FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-07
Device Publish Date2015-09-01

On-Brand Devices [Medisystems Hemodialysis Blood Tubing Sets]

M535B36605M67925B3-6605M6792
M535B36604M67925B3-6604M6792
M535B34630M47055B3-4630M4705
M535B33632M37055B3-3632M3705
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.