FDA UDI
In Commercial Distribution
🇺🇸 United States
DermaTherm
DI: 10815236020060
·
Model: 2150PB
·
LCR HALLCREST, LLC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
250
Basic Information
- Brand Name
- DermaTherm
- Primary DI
- 10815236020060
- Version / Model
- 2150PB
- Catalog Number
- 2150PB
- Company Name
- LCR HALLCREST, LLC.
- Labeler DUNS
- 059247507
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2020-02-24
- Public Version Status
- Update
- Public Device Record Key
- 654b0a11-ff9e-4523-a02b-13edbe2bd9a7
Device Description
Sharn temperature indicators read and display skin temperature. Use these indicators in your Pain Management Department to diagnose RSD, as well as to assess the effectiveness of nerve blocks within minutes by watching for a sympathetic rise in temperature. They are also useful when doing EMGs.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| KPD | Strip, Temperature, Forehead, Liquid Crystal | General Hospital | 880.2200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33618 | Liquid-crystal patient thermometer, single-use | A device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10815236020060 | GS1 | ||||
| Unit of Use | 00815236020063 | GS1 |
Customer Contacts
- Phone
- 1-800-325-3671
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 60 – 104 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity