AccessGUDID - DEVICE: TD 200® (B205CSTD2001)

GUDID

Device Identifier (DI) Information

Brand Name: TD 200®
Version or Model: TD 200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CS-TD-200
Company Name: CS MEDICAL, LLC

Primary DI Number: B205CSTD2001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 603864294 *Terms of Use

Device Description: TD 200® Automated TEE Probe Disinfector

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61673	Ultrasound imaging transducer washer-disinfector (chemical)	A dedicated electrically-powered unit intended to be used to wash and disinfect ultrasound imaging transducers with the use of appropriate cleaning methods and chemical disinfection. It is typically a stand-alone unit with a washing/disinfecting chamber designed to accept an ultrasound imaging transducer (probe).	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192228	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8787cc5d-fca1-4d79-9857-5c8953680ffc
Public Version Date: October 18, 2023
Public Version Number: 3
DI Record Publish Date: April 15, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES