HM70 EVO

GUDID 08809725791987

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system
Primary Device ID08809725791987
NIH Device Record Key1ff800d6-9617-4df3-b62f-a87a9759c031
Commercial Distribution StatusIn Commercial Distribution
Brand NameHM70 EVO
Version Model NumberUSS-M7ENLC0/US
Company DUNS687785691
Company NameSAMSUNG MEDISON CO., LTD.
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
GS108809725791987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-12
Device Publish Date2021-08-04

On-Brand Devices [HM70 EVO]

08809725794100USS-M7EPC30/US
08809725793424USS-M7EPF30/US
08809725793240USS-M7EPF30/US
08809725793066USS-M7EPCC0/US
08809725792960USS-M7ENF30/US
08809725792786USS-M7ENCC0/US
08809725792601USS-M7ENC30/US
08809725792342USS-M7ENNC0/US
08809725792168USS-M7ENN30/US
08809725791987USS-M7ENLC0/US
08809725791802USS-M7ENL30/US
08809725791628USS-M7ENFC0/US
08809725791420USS-M7EPF10/US
08809725791246USS-M7EPC10/US
08809725791147USS-M7ENN10/US
08809725790966USS-M7ENL10/US
08809725790782USS-M7ENF10/US
08809725790607USS-M7ENC10/US
08809725819070USS-M7EPFCB/US
08809725818899USS-M7EPF1B/US
08809725818714USS-M7EPCCB/US
08809725818530USS-M7EPC1B/US
08809725818332USS-M7ENNCB/US
08809725818158USS-M7ENN1B/US
08809725817977USS-M7ENLCB/US
08809725817793USS-M7ENL1B/US
08809725817618USS-M7ENFCB/US
08809725817434USS-M7ENF1B/US
08809725817250USS-M7ENCCB/US
08809725817076USS-M7ENC1B/US
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