FDA UDI
In Commercial Distribution
🇺🇸 United States
MRV Contoller
DI: B199GDMRVM0
·
Model: GDMRV-M
·
PLANER LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MRV Contoller
- Primary DI
- B199GDMRVM0
- Version / Model
- GDMRV-M
- Company Name
- PLANER LIMITED
- Labeler DUNS
- 217190495
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2019-10-28
- Public Version Status
- Update
- Public Device Record Key
- 88eed05c-b17f-4187-a08d-4ea6ae3caf32
Device Description
MRV Controller
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
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KSP | Apparatus, Cell-Freezing And Reagents | Hematology | 864.9225 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35829 | Freezer control unit, programmable | A mains electricity (AC-powered) unit used together with a specific freezer where it is important that a certain predetermined freezing pattern is followed in order to preserve the contents of the freezer. This pattern may differ according to various considerations, e.g., lowering of temperature by steps over a given time. A pre-set program will be imposed upon the freezer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B199GDMRVM0 | HIBCC |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius