FDA UDI
Not in Commercial Distribution
🇺🇸 United States
American Red Cross
DI: B268Y79160
·
Model: Y7916
·
TOMY INTERNATIONAL, 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
- American Red Cross
- Primary DI
- B268Y79160
- Version / Model
- Y7916
- Catalog Number
- Y7916
- Company Name
- TOMY INTERNATIONAL, INC.
- Labeler DUNS
- 065183758
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-31
- Public Version
- 2
- Public Version Date
- 2025-06-20
- Public Version Status
- Update
- Public Device Record Key
- 518a2650-d194-43e1-a1cb-4674c2fc3103
- Distribution End Date
- 2025-01-01
Device Description
Thermometer
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 37340 | General-purpose patient temperature probe, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B268Y79161 | HIBCC | Retail | 1 | Not in Commercial Distribution | 2025-01-01 |
| Primary | B268Y79160 | HIBCC | ||||
| Package | B268Y791695 | HIBCC | Master Carton | 24 | Not in Commercial Distribution | 2025-01-01 |