FDA UDI
Not in Commercial Distribution
🇺🇸 United States
B Medical Systems
DI: 05450104532450
·
Model: MP380CS
·
B Medical Systems SARL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- B Medical Systems
- Primary DI
- 05450104532450
- Version / Model
- MP380CS
- Catalog Number
- 991.6789.52
- Company Name
- B Medical Systems SARL
- Labeler DUNS
- 377142935
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-27
- Public Version
- 3
- Public Version Date
- 2021-12-08
- Public Version Status
- Update
- Public Device Record Key
- a7463e3b-ab17-425e-b3cd-a3ce658b09a4
- Distribution End Date
- 2020-02-11
Device Description
Pharmacy refrigerator/ freezer
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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| JRM | Freezer | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63326 | Pharmacy refrigerator/freezer, mains-powered | A mains electricity (AC- or DC-powered) fridge/freezer designed for the storage of pharmaceutical products (e.g., medications, live virus vaccines), reagents and other related materials both at refrigerated temperatures (1 to 6 °C) and in a frozen state (-18 to -30 °C). It includes refrigeration and freezing compartments with internal shelving, controls, sensors and alarms to signal out-of-range temperatures and power failures; its interior is typically corrosion-resistant to minimize the risk of adulteration, contamination, and/or corrosion of contents. The refrigeration unit is typically equipped with a safety thermostat to protect the products from freezing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05450104532450 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 70 Degrees Celsius