FDA UDI
In Commercial Distribution
🇺🇸 United States
Autonomous Portable Refrigeration Unit
DI: 00860006680909
·
Model: 6L-2
·
Delta Development Team, Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Autonomous Portable Refrigeration Unit
- Primary DI
- 00860006680909
- Version / Model
- 6L-2
- Company Name
- Delta Development Team, Inc
- Labeler DUNS
- 081279605
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-31
- Public Version
- 1
- Public Version Date
- 2021-06-08
- Public Version Status
- New
- Public Device Record Key
- b28d75f1-b037-4884-83be-189c7fa7c1c7
Device Description
Portable blood refrigerator, battery powered, 6 liter
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 |
|---|---|---|---|---|
| 35486 | Blood refrigerator | An electrically-powered device intended to be used to store and/or transport whole blood and blood components (e.g., blood cells, plasma) while keeping them cold (temperatures from 1° to 6° Celsius). It may include handles and/or wheels for transportation, internal shelving for storage and easy location of blood containers (e.g., bags); a corrosion-resistant (typically stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; and sensors, controls, monitors, chart recorders (week-long recordings are typical), and alarms (over temperature, under temperature, and power failure). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860006680909 | GS1 | ||||
| Previous | 00195893765478 | GS1 |
Customer Contacts
- Phone
- 8443735966
- [email protected]