FDA UDI
In Commercial Distribution
🇺🇸 United States
HydraTherm
DI: 00853904006803
·
Model: HT-R12-DW
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HydraTherm
- Primary DI
- 00853904006803
- Version / Model
- HT-R12-DW
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-21
- Public Version
- 3
- Public Version Date
- 2023-09-13
- Public Version Status
- Update
- Public Device Record Key
- a792958b-27f5-48c9-9b30-3e7d6d88f2c2
Device Description
HydraTherm Heater-Deluxe, Divider Rack System, 12x HydraHeat Packs (120V)
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
- No
- 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 |
|---|---|---|---|---|
| IRQ | Unit, Heating, Powered | Physical Medicine | 890.5950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38469 | Hot therapy pack heating unit | A mains electricity (AC-powered) device used to heat the contents of a reusable hot therapy pack to temperatures appropriate to apply heat therapy to the human body. This device, also known as a hydrocollator, typically consists of a stainless steel container, shelves, trays, or drawers that facilitate the heating and handling of the many hot therapy packs, and heating elements that heat the packs to a specified temperature so that the they are conditioned for reuse when needed. It is typically used in accident and emergency (A&E) rooms, rehabilitation facilities and for physiotherapy treatments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853904006803 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]