PlasmaWave Tube Set PW15

GUDID 00850998008379

Replacement tube set for the PlasmaWave system.

Manamed, Inc.

Intermittent venous compression system
Primary Device ID00850998008379
NIH Device Record Key43597eeb-0f81-483b-95a3-d4b33796dfdf
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlasmaWave Tube Set
Version Model NumberPW15
Catalog NumberPW15
Company DUNS084042331
Company NameManamed, Inc.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8885080712
Emailsupport@manamed.com
Phone8885080712
Emailsupport@manamed.com
Phone8885080712
Emailsupport@manamed.com
Phone8885080712
Emailsupport@manamed.com
Phone8885080712
Emailsupport@manamed.com
Phone8885080712
Emailsupport@manamed.com
Phone8885080712
Emailsupport@manamed.com
Phone8885080712
Emailsupport@manamed.com
Phone8885080712
Emailsupport@manamed.com
Phone8885080712
Emailsupport@manamed.com
Phone8885080712
Emailsupport@manamed.com
Phone8885080712
Emailsupport@manamed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850998008379 [Primary]

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 Date2025-09-19
Device Publish Date2025-09-11

Devices Manufactured by Manamed, Inc.

00810113682730 - ManaSlide2025-12-03 ManaSlide is a patient transfer blanket designed to assist in patient positioning in a bed or for moving a patient from a bed to
00810113682969 - ManaEZ Single Panel Knee Immobilizer 18"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113682976 - ManaEZ Single Panel Knee Immobilizer 20"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113682983 - ManaEZ Single Panel Knee Immobilizer 24"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113682990 - ManaEZ 3 Panel Knee Immobilizer 18"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113683003 - ManaEZ 3 Panel Knee Immobilizer 20"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113683010 - ManaEZ 3 Panel Knee Immobilizer 24"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113683072 - Extension Panel - Zynex Pro Hybrid LSO 6372025-12-03 The Zynex Pro Hybrid LSO 637 is a universal sacral-lubmar orthosis designed with our patent pending chord compression system wit

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.