FDA UDI
In Commercial Distribution
🇺🇸 United States
DataTherm II
DI: 00614801150118
·
Model: Datatherm II
·
R.G. ENTERPRISES (U.S.A.), INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DataTherm II
- Primary DI
- 00614801150118
- Version / Model
- Datatherm II
- Catalog Number
- 501501
- Company Name
- R.G. ENTERPRISES (U.S.A.), INC.
- Labeler DUNS
- 928998905
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2020-05-07
- Public Version Status
- Update
- Public Device Record Key
- adf690e9-544b-408f-9ddc-8480d9f57103
Device Description
Lightweight portable continuous temperature monitor used to measure human body temperature and stores temperature readings at preset time intervals. Features on/off, mode access and scrolling feature buttons, special Lock feature for safety, belt clip on back of monitor, features both High and Low adjustable alarm settings, uses 2, 1.5 volt AA batteries, disposable 1M or 2M temperature probes, dimensions (3.16 x 2.37 x .71).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14034 | Continuous electronic patient thermometer, battery-powered | A battery-powered, electronic instrument designed to continuously measure (monitor) a patient's body temperature (e.g., during the administration of general anaesthesia, treatment of hypothermia and hyperthermia). It comprises an electronic unit and an attached probe that detects and converts the changes in temperature into variations of an electric characteristic, e.g., resistance or voltage. These variations of the electric characteristic are processed in the electronic circuits and continuously displayed as temperature readings. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16148015015013 | GS1 | Hard Black Case | 1 | In Commercial Distribution | |
| Primary | 00614801150118 | GS1 |
Customer Contacts
- Phone
- 248-504-6726
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070878 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 83 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -14 – 140 Degrees Fahrenheit