FDA UDI
In Commercial Distribution
🇺🇸 United States
Hydrotherapy Whirlpool
DI: 00645724003151
·
Model: P-15-MU-0001
·
Whitehall Manufacturing Co
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Hydrotherapy Whirlpool
- Primary DI
- 00645724003151
- Version / Model
- P-15-MU-0001
- Catalog Number
- P-15-MU-0001
- Company Name
- Whitehall Manufacturing Co
- Labeler DUNS
- 008312423
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-17
- Public Version
- 1
- Public Version Date
- 2018-08-17
- Public Version Status
- New
- Public Device Record Key
- 5721f06a-839a-47c3-952c-f4cb0e151c96
Device Description
MOBILE PODIATRY WHIRLPOOL less TURBINE
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
- 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 |
|---|---|---|---|---|
| ILJ | Bath, Hydro-Massage | Physical Medicine | 890.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14429 | Hydro-massage turbine | A mains electricity (AC-powered) device with a motor and impeller designed to be submerged in a water bathtub to aerate and circulate the water (whirlpool effect) for hydrotherapy, typically therapeutic massage for patients with musculoskeletal conditions. | No | Active |
| 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 | 00645724003151 | GS1 |
Customer Contacts
- Phone
- (800) 782-7706
- [email protected]