TD 200®

Primary DI: B205CSTD2001
Brand: TD 200®
Company: CS MEDICAL, LLC
Model: TD 200
Catalog number: CS-TD-200
Device description: TD 200® Automated TEE Probe Disinfector
Published: 2020-04-15
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
Code	Name
PSW	High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
PSW	High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid	Radiology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K192228	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K192228	000	CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant	Cs Medical, LLC	2020-04-01	PSW

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
B205CSTD2001	Primary	HIBCC	0

GMDN Terms#

Term, Definition table
Term	Definition
Ultrasound imaging transducer washer/disinfector	A dedicated, mains electricity (AC-powered) unit intended to be used to wash and disinfect ultrasound imaging system transducers with the use of appropriate cleaning and disinfectant solutions. It is typically a stand-alone unit with a washing/disinfecting chamber designed to accept an ultrasound imaging transducer (probe).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number: 603864294
Device count: 1
Serial number: true
Manufacturing date on label: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
B205CS2027901	QwikCheck®	202790	CS-202790	2023-07-31
B205CSECD1001	Ethos®	ECD-100	CS-ECD-100	2023-07-31
B205CSTCD1000	TEEClean®	CS-TCD-100		2019-09-25
B205TD100A0	TD 100®	TD 100	CS-TD-100	2016-09-16
B205TD100B0	TD 100®	TD 100	CS-TD-100	2016-11-11
B205CSAQ31	AquaCide®	AQ-3	CS-AQ-3	2023-07-31
B205CSTD121	TD-12®	TD-12	CS-TD-12	2020-04-15
B205TD8A1	TD-8®	TD-8	CS-TD-8	2016-11-11
B205TD5A1	TD-5®	TD-5	CS-TD-5	2016-09-16

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
B205CSECD1001	Ethos®	CS MEDICAL, LLC	PSW	2023-07-31
B205CSTCD1000	TEEClean®	CS MEDICAL, LLC	PSW	2019-09-25