FDA UDI
In Commercial Distribution
🇺🇸 United States
Hilo-Bath TR1700 WITHOUT MIXER, AUS
DI: 07350016061902
·
Model: 05191714
·
Tr Equipment AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hilo-Bath TR1700 WITHOUT MIXER, AUS
- Primary DI
- 07350016061902
- Version / Model
- 05191714
- Company Name
- Tr Equipment AB
- Labeler DUNS
- 354437485
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-12
- Public Version
- 1
- Public Version Date
- 2023-12-20
- Public Version Status
- New
- Public Device Record Key
- 4d1c24fb-2f40-4934-b4ec-7fbe5dca7a2c
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KTC | Bath, Sitz, Nonpowered | Physical Medicine | 890.5125 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14450 | Hydrotherapy bath/tank | A bathtub or tank designed to be filled with warm water and occupied by a patient for the application of various forms of physical hydrotherapy such as water jet massage or aquatic exercise, typically to help treat musculoskeletal pain and stiffness or for physical rehabilitation; it is not dedicated to flotation therapy. It may have built-in water jet nozzles or an external heating/pump system to heat and circulate the water (whirlpool effect). This device is intended to be used in a healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350016061902 | GS1 |