FDA UDI
In Commercial Distribution
🇺🇸 United States
Whirlpool Turbine
DI: 00645724001997
·
Model: AW-607T
·
Whitehall Manufacturing Co
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Whirlpool Turbine
- Primary DI
- 00645724001997
- Version / Model
- AW-607T
- Catalog Number
- AW-607T
- Company Name
- Whitehall Manufacturing Co
- Labeler DUNS
- 008312423
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-14
- Public Version
- 1
- Public Version Date
- 2018-08-14
- Public Version Status
- New
- Public Device Record Key
- 12e99122-fd40-41f4-ab86-e0e2c1f8da00
Device Description
Turbine for Little Champ Whirlpool with Separate Drain Pump
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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00645724001997 | GS1 |
Customer Contacts
- Phone
- (800) 782-7706
- [email protected]