FDA UDI
In Commercial Distribution
🇺🇸 United States
HILOTHERM Homecare
DI: 04250387101647
·
Model: HTP1 Pro
·
Hilotherm GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HILOTHERM Homecare
- Primary DI
- 04250387101647
- Version / Model
- HTP1 Pro
- Catalog Number
- 00100010
- Company Name
- Hilotherm GmbH
- Labeler DUNS
- 332153704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-21
- Public Version
- 1
- Public Version Date
- 2024-05-29
- Public Version Status
- New
- Public Device Record Key
- 8ccf4136-cce5-4796-9d82-2020e5ab3a3c
Device Description
HILOTHERM Homecare - Cooling device
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 |
|---|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | Physical Medicine | 890.5720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42463 | Circulating-fluid localized thermal therapy system control unit | An electrically-powered device intended to be used as part of a localized circulating-fluid thermal therapy system to pump heated and/or cooled fluid (e.g., water) through an externally applied pack (not included) for localized hot and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It includes a fluid pump and either a heater, or a means for cold therapy (e.g., refrigeration unit, permitting addition of independently cooled ice water) or both; it does not include an air pump for wrap inflation. It is intended for use in both professional and home settings. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250387101647 | GS1 |