ManaFlow52 MFLOW2

GUDID 00850998008287

Compressible Limb Sleeve Device, Pneumatic compressor, segmental home model without calibrated gradient pressure

MANAMED INC

Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system
Primary Device ID00850998008287
NIH Device Record Key2467b91d-c938-4caf-ae21-268ba1484140
Commercial Distribution StatusIn Commercial Distribution
Brand NameManaFlow52
Version Model NumberMFLOW52
Catalog NumberMFLOW2
Company DUNS084042331
Company NameMANAMED INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850998008287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSleeve, Limb, Compressible

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

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00850998008904 - ManaMed2024-05-08 The ManaFlow is a four-chamber tubeless pneumatic compression device used to treat lymphedema or aid in the prevention of DVT. T
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