FDA UDI
Not in Commercial Distribution
🇺🇸 United States
B Medical Systems
DI: 05450104533488
·
Model: UF755G
·
B Medical Systems SARL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- B Medical Systems
- Primary DI
- 05450104533488
- Version / Model
- UF755G
- Catalog Number
- 991.7056.51
- 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
- 2
- Public Version Date
- 2020-02-12
- Public Version Status
- Update
- Public Device Record Key
- 42668c6f-3fb6-4ea5-bc2a-c0e4d91a109f
- Distribution End Date
- 2020-02-11
Device Description
Ultra Low 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 |
|---|---|---|---|---|
| 40513 | Ultralow-temperature laboratory freezer | A mains electricity (AC-powered) freezer designed for the storage of laboratory products and sample materials, e.g., in vitro diagnostic (IVD) reagents and laboratory tissue/body fluid samples that require extremely low temperatures, usually in the range from -40 to -90? Celsius. It will typically have a corrosion resistant (typically stainless steel) interior minimizing the risk of adulteration, contamination, and/or corrosion of the contents and a shelving configuration appropriate for storage/easy localization of the products. It will typically be programmable, have defrost capabilities, a built-in alarm system to warn against temperature variations, and a recorder to record events. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05450104533488 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 70 Degrees Celsius