ManaFlow51 MFLOW51

GUDID 00850998008270

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

MANAMED INC

Sequential venous compression system
Primary Device ID00850998008270
NIH Device Record Key3830e371-0ec7-49c2-95c1-734361f5c04b
Commercial Distribution StatusIn Commercial Distribution
Brand NameManaFlow51
Version Model NumberMFLOW51
Catalog NumberMFLOW51
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
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
GS100850998008270 [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

Devices Manufactured by MANAMED INC

00850998008102 - ManaMed 2024-06-10 Reusable universal size compression calf garment, increases venous blood flow to help prevent deep vein thrombosis.
00810113681092 - ManaMed Inc2024-06-03 Reusable extra large size compression calf garment, increases venous blood flow to help prevent deep vein thrombosis.
00810113683218 - ManaMed2024-05-08 ManaFlexx 2 is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is singl
00850998008089 - ManaMed2024-05-08 ManaFlexx 2 is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is singl
00850998008423 - ManaMed2024-05-08 ManaFlexx 2 is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is singl
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
00810113682655 - ManaMed Inc2023-09-05 ManaCold Platinum Ankle Pad attachment is used to decrease pain, swelling, and muscle spasms after surgery or injury. The cold t
00810113682662 - ManaMed Inc2023-09-05 ManaCold Platinum Back Pad attachment is used to decrease pain, swelling, and muscle spasms after surgery or injury. The cold th

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.