FDA UDI
In Commercial Distribution
🇺🇸 United States
Celbrea TMD
DI: B737WC0010
·
Model: WC0010
·
WELWAZE MEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Celbrea TMD
- Primary DI
- B737WC0010
- Version / Model
- WC0010
- Catalog Number
- WC0010
- Company Name
- WELWAZE MEDICAL INC
- Labeler DUNS
- 081093113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-16
- Public Version
- 1
- Public Version Date
- 2023-02-24
- Public Version Status
- New
- Public Device Record Key
- 6e094393-8f8c-4b3a-b570-609942a0d217
Device Description
Breast Thermal Activity Indicator
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYA | System, thermographic, liquid crystal, nonpowered (adjunctive use) | Obstetrics/Gynecology | 884.2982 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B737WC0010 | HIBCC |
Customer Contacts
- Phone
- +1(786)537-6183
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K832989 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius