FDA UDI
In Commercial Distribution
🇺🇸 United States
TempAlert II
DI: 30815236020323
·
Model: 8501-II-CE
·
LCR HALLCREST, LLC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- TempAlert II
- Primary DI
- 30815236020323
- Version / Model
- 8501-II-CE
- Catalog Number
- 8501-II-CE
- Company Name
- LCR HALLCREST, LLC.
- Labeler DUNS
- 059247507
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-10-26
- Public Version
- 1
- Public Version Date
- 2020-11-03
- Public Version Status
- New
- Public Device Record Key
- 0744809f-66c0-4034-a9b8-bbc8769740b9
Device Description
TempAlert II Liquid Crystal Temperature Trend Indicator - CE Marked
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00815236020322 | GS1 | ||||
| Primary | 30815236020323 | GS1 | ||||
| Package | 40815236020320 | GS1 | Outer Box | 1 | In Commercial Distribution |
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