FDA.reportPublic FDA data

Reverso Clamp Flow Reversing Interconnector for Hemodialysis Blood Tubing Set

Primary DI
M535M89001E5
Brand
Reverso Clamp Flow Reversing Interconnector for Hemodialysis Blood Tubing Set
Company
MEDISYSTEMS CORPORATION
Model
M8-9001E
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOCAccessories, Blood Circuit, Hemodialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOCAccessories, Blood Circuit, HemodialysisGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M535M89001E5PackageHIBCC80In Commercial Distribution
M535M89001E0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis blood tubing set, single-useA collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from moisture, freezing and heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-697-8243info@nxstage.com

Regulatory Flags#

DUNS number
061310132
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M535M820062ViraGuard Viral Blocking Patient Transducer ProtectorM8-20062015-09-01
M535M89001E0Reverso Clamp Flow Reversing Interconnector for Hemodialysis Blood Tubing SetM8-9001E2015-09-01
M535SLE3000M30950Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 SeriSLE-3000M30952015-09-01
M535SLE3010M30960Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog SerieSLE-3010M30962015-09-01
M535SLE3011M30980Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog SerieSLE-3011M30982015-09-01
M535SLE3000M30955Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 SeriSLE-3000M30952015-09-01
M535SLE3010M30965Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog SerieSLE-3010M30962015-09-01
M535SLE3011M30985Streamline Express Dialyzer with Preattached Tubing Set For B.Braun Dialog SerieSLE-3011M30982015-09-01
00842289100879Medisystems Hemodialysis Fistula Needle Set with MasterGuardS9-4005MG2016-09-16
00842289100886Medisystems Hemodialysis Fistula Needle Set with MasterGuardS9-4006MG2016-09-16
00842289100893Medisystems Hemodialysis Fistula Needle Set with MasterGuardS9-4007MG2016-09-16
00842289100909Medisystems Hemodialysis Fistula Needle Set with MasterGuardS9-4015MG2016-09-16
00842289100916Medisystems Hemodialysis Fistula Needle Set with MasterGuardS9-4016MG2016-09-16
00842289100923Medisystems Hemodialysis Fistula Needle Set with MasterGuardS9-4017MG2016-09-16
00842289100428Medisystems Hemodialysis Fistula Needle Set with MasterGuardD9-7015MG2016-09-16
00842289100435Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuardD9-2015MG2016-09-16
00842289100442Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuardD9-2015MG2016-09-16
00842289100459Medisystems Hemodialysis Fistula Needle Set with MasterGuardD9-7016MG2016-09-16
00842289100466Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuardD9-2016MG2016-09-16
00842289100473Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuardD9-2016MG2016-09-16

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