FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ice o therm pro
DI: 00683601000060
·
Model: contrast
·
Saringer Life Science Technologies Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ice o therm pro
- Primary DI
- 00683601000060
- Version / Model
- contrast
- Company Name
- Saringer Life Science Technologies Inc
- Labeler DUNS
- 243385601
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-25
- Public Version
- 5
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- 65fdd34f-f126-4d2f-ace9-b3e3244f0c07
- Distribution End Date
- 2018-08-08
Device Description
the ice o therm pro is used for applying controlled localized contrast ( hot and cold ) to a specific part of the body.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| IRT | Pad, Heating, Powered | Physical Medicine | 890.5740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62194 | Electric pad localized-body heating system | An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00683601000060 | GS1 |
Customer Contacts
- Phone
- 905 640 0060
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius