Level 1

Primary DI
20695085000522
Brand
Level 1
Company
SMITHS MEDICAL MD, INC.
Model
MTS-TC8
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DTWMONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K873206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K873206000MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLERespiratory Support Products, Inc.1987-09-30DTW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10695085000525PackageGS120In Commercial Distribution
20695085000522PackageGS1200In Commercial Distribution
30695085000529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1069508500052510695085000525
2069508500052220695085000522
3069508500052930695085000529

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, single-useA temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106712748
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30610586043325Level 1SWU-20012016-10-11
30610586043332Level 1SWU-20022016-10-11
30610586043349Level 1SWU-20032016-10-11
30610586043356Level 1SWU-20042016-10-11
30610586043363Level 1SWU-20072016-10-11
30610586043387Level 1SWU-20092016-10-11
30610586043394Level 1SWU-20102016-10-11
30610586043400Level 1SWU-20112016-10-11
30610586043417Level 1SWU-20132016-10-11
30610586043424Level 1SWU-2014L2016-10-11
30610586043431Level 1SWU-2014R2016-10-11
30610586043448Level 1SWU-20162016-10-11
30610586043455Level 1SWU-20182016-10-11
30610586043479Level 1SWU-21132016-10-11
30695085002769Level 1SW-2014L2016-10-11
30695085002776Level 1SW-2014R2016-10-11
30351688428350Portex0082012021-02-23
30610586016534Deltec21-2905-012015-09-01
30610586025635Deltec21-2770-242017-01-24
30610586025659Deltec21-2861-242016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850000067134Anivia SG1000 Pump ConsoleAPMTD, Inc.DTW2024-09-11
30695085000529Level 1ICU MEDICAL, INC.DTW2016-10-14
30695085000536Level 1ICU MEDICAL, INC.DTW2016-10-14
30695085000543Level 1ICU MEDICAL, INC.DTW2016-10-14
20695085000539Level 1SMITHS MEDICAL MD, INC.DTW2016-10-14
10695085000549Level 1SMITHS MEDICAL MD, INC.DTW2016-10-14
00886799000212Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDTW2016-09-23
00886799000229Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDTW2016-09-23
00886799000236Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDTW2016-09-23
00886799000342Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDTW2016-09-23
00886799001721Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDTW2016-09-23
00886799000199Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDTW2015-09-24