RENASYS GO 66801558

GUDID 30040565126952

RENASYS GO Class II Power Supply

SMITH & NEPHEW MEDICAL LIMITED

Basic power supply, reusable
Primary Device ID30040565126952
NIH Device Record Keyc0da659a-703d-43c5-acb8-4660970b79de
Commercial Distribution StatusIn Commercial Distribution
Brand NameRENASYS GO
Version Model Number66801558
Catalog Number66801558
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 Numbertrue
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
GS100040565126951 [Primary]
GS130040565126952 [Package]
Contains: 00040565126951
Package: Case [10 Units]
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 Date2021-07-22
Device Publish Date2016-12-02

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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