WoundPro+ 300cc Advanced Canister w/5' Tubing

GUDID 00851978007634

WoundPro+ 300cc Advanced Canister w/5' Tubing, 16 per case

Pensar Medical, LLC

Negative-pressure wound therapy system canister
Primary Device ID00851978007634
NIH Device Record Keyf8bc323b-089e-4889-85b5-6e9f1ea93b66
Commercial Distribution StatusIn Commercial Distribution
Brand NameWoundPro+ 300cc Advanced Canister w/5' Tubing
Version Model Number8463540 0916
Company DUNS079262228
Company NamePensar Medical, LLC
Device Count16
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851978007634 [Unit of Use]
GS110851978007631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMPNegative Pressure Wound Therapy Powered Suction Pump

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-22
Device Publish Date2025-01-14