FDA UDI
In Commercial Distribution
🇺🇸 United States
Bashan
DI: 06970567470155
·
Model: TDP-124F,TDP-166F
·
Chongqing Yuhe Medical Instruments Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bashan
- Primary DI
- 06970567470155
- Version / Model
- TDP-124F,TDP-166F
- Company Name
- Chongqing Yuhe Medical Instruments Co., Ltd.
- Labeler DUNS
- 527128787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-06
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c2efe8ab-6776-4630-8f7d-9cb854db44da
Device Description
Bashan TDP Heat Lamp, including TDP-124D/166D and TDP-124F/166F, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help minor muscular back pain.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35147 | Musculoskeletal infrared phototherapy unit, non-wearable | A mains electricity (AC-powered) device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970567470155 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162590 | 000 |