System M ® 3003-030-013

GUDID 05060434420176

Ultra Low Flow - (0.05 - 0.5 L/min)

SPECTRUM MEDICAL LIMITED

Extracorporeal blood gas/pH monitor
Primary Device ID05060434420176
NIH Device Record Key2f851fc0-7baa-4440-a86f-f8c26fa8afa6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSystem M ®
Version Model NumberGas Module
Catalog Number3003-030-013
Company DUNS516398679
Company NameSPECTRUM MEDICAL LIMITED
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441242650120
Emaileusales@spectrummedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060434420176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

On-Brand Devices [System M ®]

05060434420237SO2 SO2 Twin
05060434420206Exhaust Module for use with Gas Modules as part of Gas Management System
05060434420190High Flow - (1.0 - 7.0 L/min)
05060434420183Low Flow - (0.5 - 3.0 L/min)
05060434420176Ultra Low Flow - (0.05 - 0.5 L/min)
05060434420169High Flow - (1.0 - 7.0 L/min) - High Flow Gas Module (3003-030-010) & Exhaust Module (3003-031-
05060434420152Low Flow - (0.5 - 3.0 L/min) - Low Flow Gas Module (3003-030-011) & Exhaust Module (3003-031-00
05060434420145Ultra Low Flow - (0.05 - 0.5 L/min) - Ultra Low Flow Gas Module (3003-030-013) & Exhaust Module
05060434420084Tube ID 3/16" x Wall 1/16" (OD 5/16")
05060434420077Tube ID 1/4" x Wall 1/16" (OD 3/8")
05060434420060Tube ID 1/4" x Wall 3/32" (OD 7/16")
05060434420053Tube ID 3/8" x Wall 3/32" (OD 9/16")
05060434420046Extracorporeal Blood Parameter Monitor
05060434420022Extracorporeal Blood Parameter Monitor
05060434420015Data Management Monitor

Trademark Results [System M]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYSTEM M
SYSTEM M
79226097 not registered Live/Pending
Glen Dimplex Deutschland GmbH
2017-11-17

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