FDA.reportPublic FDA data

VersiPD

Primary DI
00840861102297
Brand
VersiPD
Company
Fresenius Usa, Inc.
Model
130832
Device description
VersiPD Dialysate Solution Bag Case
Published
2023-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K212522000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212522000Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLC2022-04-15FKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840861102297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840861102297008408611022978408611022970840861102297

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal dialysis systemAn assembly of devices consisting of functional units [e.g., a mains electricity (AC-powered) pump, solution mixer, monitor] intended to perform peritoneal dialysis, a treatment that removes fluid and metabolic wastes from the blood by infusing dialysate into the peritoneal cavity through a catheter and a disposable tubing system, and then removing the dialysate. Diffusion of metabolic wastes from the blood to the dialysate occurs within the abdominal cavity through the pores and intercellular channels of the peritoneum. The device may automatically control the flow of dialysate into and out of the abdominal cavity.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-323-5188xx@xx.xx

Regulatory Flags#

DUNS number
076594100
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840861102280VersiPD1308312023-08-01
008408611009652008® Series Hemodialysis Machines1909042015-09-24
00840861102198VersiPD1308212023-02-14
008408611008972008® Series Hemodialysis Machines1907132015-09-30
008408611009032008® Series Hemodialysis Machines1908582015-09-30
008408611009342008® Series Hemodialysis Machines1909082016-06-06
008408611009412008® Series Hemodialysis Machines1908282015-09-24
04046241091694FreseniusM528372015-10-02
04046241091700FreseniusM528362015-10-02
04046241091717FreseniusM528382015-10-02
04046241091731FreseniusM528402015-10-02
00840861102020Crit-Line®1910581910582016-10-04
00840861101023WetAlert™ wireless wetness detector1905072015-09-24
10840861102027Crit-Line®1910581910582016-10-04
00840861100552Crit-Line®CL10041021CL100410212015-10-19
10840861100559Crit-Line®CL10041021CL100410212015-10-19
008408611008592008® Series Hemodialysis Machines1906102015-09-30
008408611008662008® Series Hemodialysis Machines1906302015-09-30
008408611008732008® Series Hemodialysis Machines1906332015-09-30
008408611009102008® Series Hemodialysis Machines1907662015-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10884450462772Peritoneal DialysisMerit Medical Systems, Inc.FKX2021-10-22
00884450462782Peritoneal DialysisMerit Medical Systems, Inc.FKX2021-06-03
10884450462789Peritoneal DialysisMerit Medical Systems, Inc.FKX2021-06-03