ViraGuard Viral Blocking Patient Transducer Protector

GUDID M535M820062

MEDISYSTEMS CORPORATION

Haemodialysis system transducer protector
Primary Device IDM535M820062
NIH Device Record Key5a30417d-51ff-45f5-a797-7141105453ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameViraGuard Viral Blocking Patient Transducer Protector
Version Model NumberM8-2006
Company DUNS061310132
Company NameMEDISYSTEMS CORPORATION
Device Count100
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

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 *Proect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Proect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Proect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Proect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Proect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Proect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Proect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Proect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Proect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Proect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Proect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Proect from moisture, freezing and excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Proect from moisture, freezing and excessive heat

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM535M820061 [Unit of Use]
HIBCCM535M820062 [Primary]
HIBCCM535M820065 [Package]
Package: [300 Units]
In Commercial Distribution

FDA Product Code

FIBProtector, Transducer, Dialysis

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-08-07
Device Publish Date2015-09-01

Devices Manufactured by MEDISYSTEMS CORPORATION

M535M820062 - ViraGuard Viral Blocking Patient Transducer Protector2025-08-07
M535M820062 - ViraGuard Viral Blocking Patient Transducer Protector2025-08-07
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M535SLE3010M30965 - Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie2021-11-18
M535SLE3011M30985 - Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog Serie2021-11-18
M535M850075 - Medisystems Medic Anti-stick Needle/Connector2020-10-20
10842289100517 - Medisystems Button Hole Needle Set with SteriPick2020-06-30
10842289100524 - Medisystems Button Hole Needle Set with SteriPick2020-06-30
10842289100531 - Medisystems Button Hole Needle Set with SteriPick2020-06-30

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