Max Pulse Max Pulse

GUDID 40191237000036

Medicore Co., Ltd.

Sphygmograph
Primary Device ID40191237000036
NIH Device Record Keyda271aec-2c4e-4ebb-9c7d-515e491caea4
Commercial Distribution StatusIn Commercial Distribution
Brand NameMax Pulse
Version Model NumberMax Pulse
Catalog NumberMax Pulse
Company DUNS688247753
Company NameMedicore Co., Ltd.
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82220562650
Emailbkyoo@medi-core.com

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100191237000038 [Primary]
GS110191237000035 [Package]
Contains: 00191237000038
Package: Carton [1 Units]
In Commercial Distribution
GS120191237000032 [Package]
Contains: 10191237000035
Package: carton [5 Units]
In Commercial Distribution
GS130191237000039 [Package]
Contains: 10191237000035
Package: carton [10 Units]
In Commercial Distribution
GS140191237000036 [Package]
Contains: 10191237000035
Package: carton [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-13
Device Publish Date2019-03-05

Devices Manufactured by Medicore Co., Ltd.

00191237000069 - IRIS-XP2021-11-09
10191237000011 - SA-3000P2019-04-18
40191237000036 - Max Pulse2019-03-13
40191237000036 - Max Pulse2019-03-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.