RENASYS GO v2 HOME 66801496

GUDID 00040565126944

RENASYS GO Pump and power supply

SMITH & NEPHEW MEDICAL LIMITED

Negative-pressure wound therapy system, battery-powered, reusable
Primary Device ID00040565126944
NIH Device Record Key5ad54023-db74-47b9-9113-3eb54102f56d
Commercial Distribution StatusIn Commercial Distribution
Brand NameRENASYS GO v2 HOME
Version Model Number66801496
Catalog Number66801496
Company DUNS216344051
Company NameSMITH & NEPHEW MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS100040565126944 [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 Date2020-05-25
Device Publish Date2020-05-15

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