FDA UDI
In Commercial Distribution
🇺🇸 United States
Dickson
DI: 00645724000006
·
Model: PB-104
·
Whitehall Manufacturing Co
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dickson
- Primary DI
- 00645724000006
- Version / Model
- PB-104
- Catalog Number
- PB-104
- Company Name
- Whitehall Manufacturing Co
- Labeler DUNS
- 008312423
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-03
- Public Version
- 3
- Public Version Date
- 2018-07-25
- Public Version Status
- Update
- Public Device Record Key
- b7e1cd00-d82d-4c76-a4e1-26dbe6aa8de3
Device Description
PARAFFIN BATH THERAPY 18 LBS. CAPACITY MOBILE PARAFFIN BATH
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 |
|---|---|---|---|---|
| IMC | Bath, Paraffin | Physical Medicine | 890.5110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35232 | Physical therapy paraffin wax bath | A mains electricity (AC-powered) tub/enclosure, with an internal heating assembly, intended to be filled with liquid paraffin wax for physical therapy. Symptomatic parts of the body (e.g., hands, fingers) are placed in the heated paraffin to relieve pain and stiffness caused by arthritis or other joint inflammation, muscle spasms, or to help stimulate circulation. Temperature settings and timing controls are typically included as part of the device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00645724000006 | GS1 |
Customer Contacts
- Phone
- (800) 782-7706
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 131 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 32 – 131 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity