FDA UDI
In Commercial Distribution
🇺🇸 United States
NOVATEMP
DI: 00817499020071
·
Model: 10-1620-001
·
NOVAMED-USA INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- NOVATEMP
- Primary DI
- 00817499020071
- Version / Model
- 10-1620-001
- Company Name
- NOVAMED-USA INC.
- Labeler DUNS
- 831531426
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-28
- Public Version
- 4
- Public Version Date
- 2021-03-15
- Public Version Status
- Update
- Public Device Record Key
- 3d0db60d-746f-47f8-9b79-1dcf5f61a59f
Device Description
12FR ESOPHAGEAL/RECTAL TEMPERATURE PROBE WITH 400 SERIES THERMISTOR
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| BZT | Stethoscope, Esophageal, With Electrical Conductors | Anesthesiology | 868.1920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35254 | General-purpose patient temperature probe, single-use | A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817499020075 | GS1 | CASE | 4 | In Commercial Distribution | |
| Package | 10817499020078 | GS1 | BOX | 40 | In Commercial Distribution | |
| Primary | 00817499020071 | GS1 |
Customer Contacts
- Phone
- 914-789-2100
- [email protected]