FDA UDI
In Commercial Distribution
🇺🇸 United States
Sharesource Connectivity Platform
DI: 45413765565692
·
Model: 5C9400
·
BAXTER INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sharesource Connectivity Platform
- Primary DI
- 45413765565692
- Version / Model
- 5C9400
- Catalog Number
- 5C9400
- Company Name
- BAXTER INTERNATIONAL INC.
- Labeler DUNS
- 005146311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-20
- Public Version
- 1
- Public Version Date
- 2020-09-28
- Public Version Status
- New
- Public Device Record Key
- 70e44d91-5587-430c-b961-56ea5c6acacc
Device Description
Sharesource is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Amia APD System.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| FKX | System, peritoneal, automatic delivery | Gastroenterology, Urology | 876.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41049 | Nephrology information system application software | An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of nephrology services. It is used by renal professionals to track disease progression, manage co-morbidities, and prepare patients for renal therapies such as haemodialysis, peritoneal dialysis, and transplant. It is typically installed into a dedicated information system for nephrology or existing mainframe or decentralized computers/networks. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 45413765565692 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151525 | 000 |