RENASYS GO 66800162

GUDID 05000223465131

RENASYS GO CARRY BAG

SMITH & NEPHEW MEDICAL LIMITED

Medical bag
Primary Device ID05000223465131
NIH Device Record Key43ff7260-b7b1-4284-993a-576ee876639f
Commercial Distribution StatusIn Commercial Distribution
Brand NameRENASYS GO
Version Model Number66800162
Catalog Number66800162
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 Batchtrue
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
GS105000223465131 [Package]
Contains: 05000223465186
Package: CASE [50 Units]
In Commercial Distribution
GS105000223465186 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-08

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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