HARIOMED

GUDID 06975183900079

Hua Yue Medical Technology Co., Ltd.

Assisted reproduction heater/incubator
Primary Device ID06975183900079
NIH Device Record Key302393cb-da68-461d-8de6-9b376092082e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHARIOMED
Version Model NumberHarioculture DI-4
Company DUNS625413598
Company NameHua Yue Medical Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106975183900079 [Primary]

FDA Product Code

PUBAccessory, Assisted Reproduction, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-24
Device Publish Date2025-03-14

On-Brand Devices [HARIOMED]

06975183900130IW-A1800D
06975183900116IW-A1800S
06975183900109IW-A1800
06975183900093Harioculture HI-4
06975183900086Harioculture HI-2
06975183900079Harioculture DI-4
06975183900062IBI-D101
06975183900055IMS-320U-S
06975183900048IMS-320D-S
06975183900031IMS-320U
06975183900024IMS-320D
06975183900178IW-A1350S
06975183900161IW-A1350C
06975183900154IW-A1350A
06975183900147IW-A950
06975183900123IW-A1800M

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