FDA UDI
In Commercial Distribution
🇺🇸 United States
Paragonix SherpaPak Cardiac Transport System
DI: 00869582000316
·
Model: SHRP-1001-001
·
Paragonix Technologies Inc
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Paragonix SherpaPak Cardiac Transport System
- Primary DI
- 00869582000316
- Version / Model
- SHRP-1001-001
- Company Name
- Paragonix Technologies Inc
- Labeler DUNS
- 961780660
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-15
- Public Version
- 3
- Public Version Date
- 2024-07-30
- Public Version Status
- Update
- Public Device Record Key
- 40e2f66a-6bf0-4153-9355-fbe62b977812
Device Description
Paragonix SherpaPak CTS Shipper Base
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MSB | System And Accessories, Isolated Heart, Transport And Preservation | Gastroenterology, Urology | 876.5880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16461 | General-purpose donor-organ preservation/transport system | A non-dedicated system designed to support and maintain any donated organ (e.g., heart, kidney, liver) during transport from the donor to the receiving hospital where the organ will be transplanted into the recipient. This system will provide technical support functions to keep the organ in as near-physiologic state as possible. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10869582000313 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00869582000316 | GS1 | ||||
| Package | 20869582000310 | GS1 | Inner Box | 1 | In Commercial Distribution | |
| Package | 00850005470267 | GS1 | Outer Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1.781.428.4828
- [email protected]