FDA UDI
In Commercial Distribution
🇺🇸 United States
Medichoice
DI: 10885632106002
·
Model: 916812A
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medichoice
- Primary DI
- 10885632106002
- Version / Model
- 916812A
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- a278dc64-e59d-4722-8a42-1eddc0fbdd90
Device Description
Kit Thermometer Digital Oral Dual-Scale Blue Cap With 20 Sheaths Not Made With Natural Rubber Latex MediChoice
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 14025 | Thermometer kit | A collection of devices intended to be used to eliminate the reprocessing, reduce the risk of breakage and cross-contamination, and reduce the variance caused by the use of more than one thermometer per patient. It typically includes a thermometer [e.g., a mercury (Hg) or alcohol thermometer] for measuring human body temperature; and other components such as holders, cases, vials, or sheaths. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885632106000 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 10885632106002 | GS1 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not Store in direct sunlight or extreme heat
- Type
- Handling Environment Temperature
- Temperature Range
- -4 – 131 Degrees Fahrenheit
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 800 – 1060 KiloPascal