FDA.reportPublic FDA data

Sharesource Connectivity Platform for Use with the Amia APD System

Primary DI
57332414206319
Brand
Sharesource Connectivity Platform for Use with the Amia APD System
Company
Vantive US Healthcare LLC
Model
5C9400
Device description
Sharesource Amia 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.
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FKXSystem, peritoneal, automatic delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKXSystem, Peritoneal, Automatic DeliveryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151525000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151525000Amia Automated PD System with SharesourceDeka Research and Development2015-10-09FKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57332414206319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5733241420631957332414206319

GMDN Terms#

Term, Definition table
TermDefinition
Nephrology information system application softwareAn 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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)284-4060US.customerservice@vantive.com

Regulatory Flags#

DUNS number
119533513
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414208028MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short5C44835C44832026-07-22
07332414254551MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWIST5C4482A5C4482A2026-07-06
07332414208417MANIFOLD SETL5C4446L5C44462026-06-22
07332414208011FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTION5C44565C44562026-01-30
07332414208264MinicapEZPC4466EZPC44662026-01-30
57332414208016FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTION5C44565C44562026-01-30
57332414208269MinicapEZPC4466EZPC44662026-01-30
07332414208479HOMECHOICE APD SET5C4469C5C4469C2025-10-16
07332414207946LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER5C41295C41292025-09-23
27332414207940LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER5C41295C41292025-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
57332414206296Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemVantive Health GmbHFKX2026-09-22
07332414202491Homechoice Claria APD CyclerVantive Health GmbHFKX2026-08-27
07332414208479HOMECHOICE APD SETVantive US Healthcare LLCFKX2025-10-16
08964004471001X-1 APD CyclerBYONYKS PRIVATE LIMITEDFKX2025-09-08
00085412030531NABaxter Healthcare SAFKX2025-08-28
50085412030536NABaxter Healthcare SAFKX2025-08-28
00840861102709LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
00840861102716LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
10840861102706LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
10840861102713LibertyFresenius Medical Care Renal Therapies Group, LLCFKX2024-03-19
00840861102280VersiPDFresenius Usa, Inc.FKX2023-08-01
00840861102211VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102228VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102235VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102617VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102198VersiPDFresenius Usa, Inc.FKX2023-02-14
10840861102218VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
10840861102225VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
10840861102232VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00840861102297VersiPDFresenius Usa, Inc.FKX2023-02-14
10840861102614VersiPDFresenius Medical Care Holdings, Inc.FKX2023-02-14
00860006810238CloudCath Connect - Patient Monitoring SoftwareGastroklenz Inc.FKX2022-08-17
00860006810245CloudCath Drain Set - Fresenius ConfigurationGastroklenz Inc.FKX2022-08-12
00860006810207CloudCath Drain Set - Baxter ConfigurationGastroklenz Inc.FKX2022-08-12
00860006810269CloudCath Drain Set - Fresenius ConfigurationGastroklenz Inc.FKX2022-08-12
00860006810283CloudCath Sensor (Sensing Hardware)Gastroklenz Inc.FKX2022-08-05
00860006810214CloudCath Sensor (Sensing Hardware)Gastroklenz Inc.FKX2022-08-05
00884450462751Peritoneal DialysisMerit Medical Systems, Inc.FKX2021-10-22
00884450462775Peritoneal DialysisMerit Medical Systems, Inc.FKX2021-10-22
10884450462758Peritoneal DialysisMerit Medical Systems, Inc.FKX2021-10-22