Level 1

GUDID 20695085000522

SMITHS MEDICAL MD, INC.

General-purpose patient temperature probe, single-use
Primary Device ID20695085000522
NIH Device Record Key54b1d2da-21cb-4bab-bfc4-26c2d88c4db3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLevel 1
Version Model NumberMTS-TC8
Company DUNS106712748
Company NameSMITHS MEDICAL MD, INC.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110695085000525 [Package]
Contains: 30695085000529
Package: BOX [20 Units]
In Commercial Distribution
GS120695085000522 [Package]
Contains: 10695085000525
Package: BOX [200 Units]
In Commercial Distribution
GS130695085000529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTWMONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-17
Device Publish Date2016-10-14

On-Brand Devices [Level 1]

00694393090986GP-200
50695085850005EQ-5000
506950858295068002950
50695085829261H-31-EN
50695085828264H-1100-ES-115V
50695085821098HL-90-40
50695085820916HL-90-SP-115
50695085820909HL-90
50695085812904H-1129
506950858002227204018
10695085403005Y-30
50695085003630EQ-5000HF-INT-115V
50695085003616EQ-5000HF-ES-115V
50695085003593EQ-5000HF-EN-115V
50695085002930H-31-ES
50695085002657EQ-5000-INT-115V
50695085002404HL-90-38
506950850018728002911
50695085001810EQ-5000-ES-115V
50695085000653SW5-HOSE-7
10695085410805PC-8
20695085403804YC-8
30695085401005L-10
30695085400305SC-3
10695085480020SW-2007
10695085460305IR-6
10695085433002F-30
10695085408000L-80
20695085407505L-70NI
10695085403609X-36
20695085403101Y-INJ
20695085402708L-270
10695085002178SW-2019
10695085002161SW-2018
10695085002147SW-2016
10695085002116SW-2013
10695085001782SW-2011
10695085001775SW-2010
20695085001475C202-3
10695085000730ES100-9
10695085000723SW-2009
20695085000614TTSP-400
20695085000607TTS-400
20695085000591TTSP-TC
10695085000587TTS-TC
20695085000577MTS-40030
20695085000560MTS-40015
20695085000553MTS-4008
10695085000549MTS-TC30
20695085000539MTS-TC15

Trademark Results [Level 1]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LEVEL 1
LEVEL 1
90156338 not registered Live/Pending
Level One HVAC Services, Inc.
2020-09-03
LEVEL 1
LEVEL 1
78974773 3424780 Live/Registered
Calandrino, Frank
2006-09-14
LEVEL 1
LEVEL 1
78962582 3260965 Dead/Cancelled
Level One HVAC Services, Inc.
2006-08-29
LEVEL 1
LEVEL 1
78452685 not registered Dead/Abandoned
Hershey Chocolate & Confectionery Corporation
2004-07-19
LEVEL 1
LEVEL 1
78367477 not registered Dead/Abandoned
PRIVATE BRANDS, INC.
2004-02-13
LEVEL 1
LEVEL 1
78300270 3370140 Dead/Cancelled
Trish McEvoy Ltd.
2003-09-15
LEVEL 1
LEVEL 1
77721761 3751508 Live/Registered
Smiths Medical ASD, Inc.
2009-04-24
LEVEL 1
LEVEL 1
77716393 3748761 Live/Registered
Smiths Medical ASD, Inc.
2009-04-17
LEVEL 1
LEVEL 1
76517287 2922048 Live/Registered
SMITHS MEDICAL ASD, INC.
2003-05-27
LEVEL 1
LEVEL 1
73645710 1458203 Live/Registered
LEVEL 1 TECHNOLOGIES, INC.
1987-02-20
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.