FDA UDI
In Commercial Distribution
🇺🇸 United States
B Medical Systems
DI: 05450104548307
·
Model: P130
·
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
- 05450104548307
- Version / Model
- P130
- Catalog Number
- 991.8316.**
- Company Name
- B Medical Systems SARL
- Labeler DUNS
- 377142935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-04
- Public Version
- 1
- Public Version Date
- 2020-03-12
- Public Version Status
- New
- Public Device Record Key
- d10f2202-7231-448f-b9af-90da8f435a24
Device Description
Pharmacy refrigerator
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 |
|---|---|---|---|---|
| 17156 | Pharmacy refrigerator | A mains electricity (AC-powered) refrigerator specially designed for cool storage of pharmaceuticals, e.g., medications or live virus vaccines. It may be provided with a built-in alarm system that warns against unexpected temperature variations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05450104548307 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 70 Degrees Celsius