Radius PCG™ 655100

GUDID 07350046131996

Masimo Sweden AB

Patient monitoring system module, carbon dioxide
Primary Device ID07350046131996
NIH Device Record Keya654be36-c3a7-415f-beb8-24ce190eda2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadius PCG™
Version Model NumberEMMA Bluetooth kPa
Catalog Number655100
Company DUNS632369067
Company NameMasimo Sweden AB
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 Datetrue
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
GS107350046131996 [Primary]

FDA Product Code

CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-27
Device Publish Date2020-10-19

On-Brand Devices [Radius PCG™]

07350046132009EMMA Bluetooth mmHg
07350046131996EMMA Bluetooth kPa

Trademark Results [Radius PCG]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RADIUS PCG
RADIUS PCG
88709652 not registered Live/Pending
MASIMO CORPORATION
2019-11-27

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