AccessGUDID - DEVICE: Celbrea TMD (B737WC0010)

GUDID

Device Identifier (DI) Information

Brand Name: Celbrea TMD
Version or Model: WC0010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WC0010
Company Name: WELWAZE MEDICAL INC

Primary DI Number: B737WC0010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081093113 *Terms of Use

Device Description: Breast Thermal Activity Indicator

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
40798	Liquid-crystal thermography system	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYA	System, thermographic, liquid crystal, nonpowered (adjunctive use)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K832989	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e094393-8f8c-4b3a-b570-609942a0d217
Public Version Date: February 24, 2023
Public Version Number: 1
DI Record Publish Date: February 16, 2023

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: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(786)537-6183
Email: francis@welwaze.com

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

FDA TOOLS & RESOURCES