RENASYS GO 66021814

GUDID 00040565125572

RENASYS GO QRG USA Only

SMITH & NEPHEW MEDICAL LIMITED

Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable Negative-pressure wound therapy system, battery-powered, reusable
Primary Device ID00040565125572
NIH Device Record Key79f9f0e3-6e5f-4f9d-8410-b783d1f5402e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRENASYS GO
Version Model Number66021814
Catalog Number66021814
Company DUNS216344051
Company NameSMITH & NEPHEW MEDICAL LIMITED
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS100040565125572 [Primary]
GS105000223491482 [Package]
Package: Case [25 Units]
Discontinued: 2020-10-07
Not in Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-10-08
Device Publish Date2016-12-01

On-Brand Devices [RENASYS GO]

05000223491000RENASYS GO Device US Only
05000223465148RENASYS GO CARRY STRAP
05000223465131RENASYS GO CARRY BAG
00040565127392Home Healthcare User Manual US Only
00040565127149Clinician User Manual US Only
00040565125572RENASYS GO QRG USA Only
30040565125306RENASYS GO Odor Filter
30040565126952RENASYS GO Class II Power Supply
30040565127331RENASYS GO 750ml Canister with Solidifier
30040565127324RENASYS GO 300ml Canister with Solidifier
30040565125290RENASYS GO O-Ring

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