FDA UDI
In Commercial Distribution
🇺🇸 United States
B Medical Systems
DI: 05450104537929
·
Model: CSF61L
·
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
- 05450104537929
- Version / Model
- CSF61L
- Catalog Number
- 991.8906.**
- Company Name
- B Medical Systems SARL
- Labeler DUNS
- 377142935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-18
- Public Version
- 1
- Public Version Date
- 2021-06-28
- Public Version Status
- New
- Public Device Record Key
- af25c0bc-32d6-4cf8-b3aa-6b132df7d387
Device Description
Plasma contact shock 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 |
|---|---|---|---|---|
| KSE | Refrigerator, Freezer, Blood Storage | Hematology | 864.9700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61548 | Rapid-contact laboratory freezer | A mains electricity (AC-powered) appliance intended to be used to rapidly freeze bags containing plasma or other biological specimens to a core temperature of -30° Celsius (-22° Fahrenheit). It typically consists of a single or multiple shelves with adjustable contact plates, between which the bags are placed for freezing. It is not intended for storage; frozen bags are subsequently transferred to an appropriate storage freezer. It has sensors, controls, and monitors to display freezing progress (time/temperature graphs). It may include associated software for documentation of data and tracing of the bags. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05450104537929 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 70 Degrees Celsius