FDA.reportPublic FDA data

TD-5®

Primary DI
B205TD5A1
Brand
TD-5®
Company
CS MEDICAL, LLC
Model
TD-5
Catalog number
CS-TD-5
Device description
TD-5® High Level Disinfectant
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051305000CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5Cs Medical, LLC2005-08-18PSW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B205TD5A1PrimaryHIBCC0
B205TD5A0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Glutaraldehyde device sterilantA liquid substance that includes glutaraldehyde as its primary agent intended to completely destroy or eliminate (sterilize) all harmful microorganisms on a medical device (e.g., surgical or dental instrument); it may also be intended for use as a high-level disinfectant. The medical device is typically bathed by the substance for a specified period of time in order to achieve high-level disinfection or sterilization. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
919-255-9472service@csmedicalllc.com

Regulatory Flags#

DUNS number
603864294
Device count
32
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B205CS2027901QwikCheck®202790CS-2027902023-07-31
B205CSECD1001Ethos®ECD-100CS-ECD-1002023-07-31
B205CSTD2001TD 200®TD 200CS-TD-2002020-04-15
B205CSTCD1000TEEClean®CS-TCD-1002019-09-25
B205TD100A0TD 100®TD 100CS-TD-1002016-09-16
B205TD100B0TD 100®TD 100CS-TD-1002016-11-11
B205CSAQ31AquaCide®AQ-3CS-AQ-32023-07-31
B205CSTD121TD-12®TD-12CS-TD-122020-04-15
B205TD8A1TD-8®TD-8CS-TD-82016-11-11

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Primary DI, Brand, Company table
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