BIOMAT SINGLE

GUDID 00860163001531

RICHWAY & FUJI BIO INC.

Electric pad localized-body heating system
Primary Device ID00860163001531
NIH Device Record Key89732df0-0baf-4265-a377-bd253dff640f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOMAT SINGLE
Version Model Number7000MX
Company DUNS080311325
Company NameRICHWAY & FUJI BIO INC.
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860163001531 [Primary]

FDA Product Code

IRTPad, Heating, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-24
Device Publish Date2025-06-16

Devices Manufactured by RICHWAY & FUJI BIO INC.

00860163001517 - BIOMAT QUEEN2025-06-24
00860163001524 - BIOMAT PROFESSIONAL2025-06-24
00860163001531 - BIOMAT SINGLE2025-06-24
00860163001531 - BIOMAT SINGLE2025-06-24
00860163001548 - BIOMAT MINI2025-06-24
00860163001555 - BIO-BELT2025-06-24
00860163001500 - BIOMAT2020-04-28

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