Celbrea TMD

Primary DI
B737WC0010
Brand
Celbrea TMD
Company
WELWAZE MEDICAL INC
Model
WC0010
Catalog number
WC0010
Device description
Breast Thermal Activity Indicator
Published
2023-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYASystem, thermographic, liquid crystal, nonpowered (adjunctive use)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYASystem, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)Obstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K832989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K832989000BREAST THERMAL ACTIVITY INDICATORBcsi Laboratories, Inc.1984-01-17KYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B737WC0010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Liquid-crystal thermography systemA system intended to be used to produce, display, and analyse images or graphical representations of the distribution of surface body temperature for the purpose of diagnosing and assessing various conditions and disease states. Sheets of cholesteric liquid crystal based materials are embedded in the outer layer of objects, e.g. blankets, pillows or mattresses that can be moulded around the body. The object changes colour based on surface temperature variations of the body parts that come in contact with the material and the colour variations are analysed using either visual assessment or software based quantitative methods.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(786)537-6183francis@welwaze.com

Regulatory Flags#

DUNS number
081093113
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106779613CARDINAL HEALTHCardinal Health 200, LLCKYA2024-09-17
50197106779611CARDINAL HEALTHCardinal Health 200, LLCKYA2024-09-17
10197106719145CARDINAL HEALTHCardinal Health 200, LLCKYA2024-07-03
50197106719143CARDINAL HEALTHCardinal Health 200, LLCKYA2024-07-03
10197106671160CARDINAL HEALTHCardinal Health 200, LLCKYA2024-05-16
50197106671168CARDINAL HEALTHCardinal Health 200, LLCKYA2024-05-16