FDA.reportPublic FDA data

Peritoneal Dialysis

Primary DI
00884450277454
Brand
Peritoneal Dialysis
Company
Merit Medical Systems, Inc.
Model
00884450277454
Published
2016-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K823296000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K823296000PC-205 TENCKHOFF CATHETER ROD OBTURATORMedigroup1983-01-26FKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450277454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450277454008844502774548844502774540884450277454

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal catheter styletA sterile thin wire/rod intended to be inserted within the lumen of a percutaneous peritoneal catheter (i.e., peritoneal dialysis catheter, peritoneal drainage catheter) to stiffen/maintain the shape of the catheter to assist introduction. It is intended to be removed once the catheter is in place. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450079973Merit Medical®Initial ReleaseK09-10089M2026-06-09
00884450101537Merit Medical®Initial ReleaseK09-143202026-06-09
00884450101568Merit Medical®Initial ReleaseK09-143212026-06-09
00884450435748SCOUT®MSG-012026-06-09
00884450486962Merit Medical®Initial ReleaseK09-144042026-06-09
00884450486993Merit Medical®Initial ReleaseK10-062032026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09
00884450826560Fountain®BIS5-135-302026-06-09
10884450114008Prelude IDeal™HPID4F11018SS2026-06-09
10884450119799Prelude EASE™JPHR6F11021PW2026-06-09
00884450467572DuraMax®CH7871030281952026-06-08
00884450469033BioFlo DuraMax®BH9651030281612026-06-08
00884450469132BioFlo DuraMax®BH9651030282112026-06-08
00884450787663Impress®C44038STS2026-06-08
10884450114855Prelude IDeal™HPID5F16021PW2026-06-08
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06
00884450110270Merit Drainage Depot™Initial ReleaseK10-03450A2026-06-06
00884450161746Merit Medical®Initial ReleaseK09-10859C2026-06-06
00884450376171One-Tie®ALR-OTE-N2026-06-06

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
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
10884450462772Peritoneal DialysisMerit Medical Systems, Inc.FKX2021-10-22
00884450462782Peritoneal DialysisMerit Medical Systems, Inc.FKX2021-06-03