ThermaCor 1200 Infusion System

GUDID 00857893006134

Rigid Fluid Reservoir

SMISSON-CARTLEDGE BIOMEDICAL, LLC

Conduction blood/fluid warmer
Primary Device ID00857893006134
NIH Device Record Key53460ba0-3751-47cc-8448-2924862bd0be
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermaCor 1200 Infusion System
Version Model NumberMR-1200
Company DUNS087687179
Company NameSMISSON-CARTLEDGE BIOMEDICAL, LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com
Phone+1(478)330-6205
Emaildonna@t3med.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857893006134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGZWarmer, thermal, infusion fluid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-15

On-Brand Devices [ThermaCor 1200 Infusion System]

00857893006219European Detachable Power Cord Set
008578930061963 Spike Set Holder
00857893006189UK Detachable Power Cord Set
10857893006155Drape
00857893006141Rigid Fluid Reservoir Holder
00857893006134Rigid Fluid Reservoir
20857893006121Extension Line
108578930061173 Spike Set
20857893006107Patient Line
20857893006091Dual Line
00857893006080Cassette
10857893006070Cassette with Dual Line
10857893006063Cassette with Patient Line
10857893006056Cassette with Patient Line and 3 Spike Set
00857893006042Replacement Power Cord
00857893006035Replacement Silpad
00857893006028Replacement Footswitch
00857893006011Replacement Component Guard
00857893006004ThermaCor 1200 Rapid Infuser
00857893006226Australia Detachable Power Cord Set

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