FDA UDI
In Commercial Distribution
🇺🇸 United States
Genius
DI: 20192253065951
·
Model: V303030
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
96
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
- Genius
- Primary DI
- 20192253065951
- Version / Model
- V303030
- Catalog Number
- V303030
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 96
- Record Status
- Published
- Publish Date
- 2025-11-10
- Public Version
- 2
- Public Version Date
- 2026-04-22
- Public Version Status
- Update
- Public Device Record Key
- 6c7662e6-5063-43a0-8f1d-5b3165de307b
Device Description
THERMOMETER PROBE COVER GENIUS 2 TYMPANIC
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SDV | Clinical Electronic Thermometer | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13116 | Electronic thermometer probe cover | A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50192253065952 | GS1 | CASE | 22 | In Commercial Distribution | |
| Primary | 20192253065951 | GS1 | ||||
| Unit of Use | 10192253065954 | GS1 |