FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PHCbi
DI: 04987905300199
·
Model: MDF-U334-PA
·
PHC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PHCbi
- Primary DI
- 04987905300199
- Version / Model
- MDF-U334-PA
- Company Name
- PHC CORPORATION
- Labeler DUNS
- 691795268
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-25
- Public Version
- 3
- Public Version Date
- 2021-04-08
- Public Version Status
- Update
- Public Device Record Key
- e833b58f-9c6c-498d-9af2-66d271288f24
- Distribution End Date
- 2021-03-31
Device Description
This equipment is designed for low temperature storage of blood and blood products.
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
- 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 |
|---|---|---|---|---|
| KSE | Refrigerator, Freezer, Blood Storage | Hematology | 864.9700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15145 | Basic laboratory freezer | A mains electricity (AC-powered) freezer designed for the storage of laboratory products, samples, test materials, chemicals or reagents that require low temperatures, usually in the range from -10? to -55? 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, 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 | 04987905300199 | GS1 |