FDA.reportPublic FDA data

Peritoneal Dialysis Catheter Adapter

Primary DI
00792079000752
Brand
Peritoneal Dialysis Catheter Adapter
Company
Medionics International Inc
Model
PCA-1010
Catalog number
PCA-1010
Published
2026-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FJSCatheter, Peritoneal, Long-Term Indwelling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJSCatheter, Peritoneal, Long-Term IndwellingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993149000PERITONEAL DIALYSIS CATHETERS AND ADAPTERSMedionics International, Inc.2000-04-28FJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792079000752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792079000752007920790007527920790007520792079000752

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal dialysis catheter adaptor, single-useA connecting device, often in two pieces, intended to be used to join a peritoneal dialysis catheter to the dialysate line during treatment. It is typically made of plastic or metal and may be used when the devices to be connected are from different manufacturers and not compatible, enabling them to mate, and/or within a mechanical connection system. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-472-6544info@medionics.com

Regulatory Flags#

DUNS number
241421320
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792079000639Peritoneal Dialysis CatheterCA-2272CA-22722026-02-02
00792079001827Faller StyletFS-404FS-4042026-02-02
00792079000424Faller StyletFS-401FS-4012018-04-09
00792079001216Faller StyletFS-402FS-4022018-04-09
00792079001223Faller StyletFS-403FS-4032018-04-09
00792079000431StyletSST-650SST-6502018-04-09
00792079000028Peritoneal Dialysis CatheterSA-1247SA-12472018-04-09
00792079000035Peritoneal Dialysis CatheterSA-1248KSA-1248K2018-04-09
00792079000141Peritoneal Dialysis CatheterSI-1231SI-12312015-09-17
00792079000196Peritoneal Dialysis CatheterCA-2262CA-22622015-09-17
00792079000219Peritoneal Dialysis CatheterCA-1162CA-11622015-09-17
00792079000226Peritoneal Dialysis CatheterCA-1157CA-11572018-04-09
00792079000264Peritoneal Dialysis CatheterCP-1241CP-12412015-09-17
00792079000356Peritoneal Dialysis CatheterSNCA-5262LSNCA-5262L2015-09-17
00792079000363Peritoneal Dialysis CatheterSNCP-5243LSNCP-5243L2015-09-17
00792079000394Peritoneal Dialysis Catheter AdapterTA-200TA-2002018-04-09
00792079000400Peritoneal Dialysis Catheter AdapterTA-300TA-3002018-04-09
00792079000592Peritoneal Dialysis CatheterSNPS-53113SNPS-531132015-09-17
00792079000967Peritoneal Dialysis CatheterSNCA-5263LFDSNCA-5263LFD2018-04-09
00792079001476Peritoneal Dialysis CatheterPSNA-100PSNA-1002015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450104484Flex-Neck®Merit Medical Systems, Inc.FJS2026-04-21
00884450773314Flex-Neck®Merit Medical Systems, Inc.FJS2026-04-21
10884521811270RitusMozarc Medical US LLCFJS2026-04-20
10884521852822ArgyleMozarc Medical US LLCFJS2026-02-06
00792079000639Peritoneal Dialysis CatheterMedionics International IncFJS2026-02-02
00792079001827Faller StyletMedionics International IncFJS2026-02-02
00884450104682Flex-Neck®Merit Medical Systems, Inc.FJS2025-12-03
10884450104689Flex-Neck®Merit Medical Systems, Inc.FJS2025-12-03
10884521852891RitusMozarc Medical US LLCFJS2025-11-27
10884521811102RitusMozarc Medical US LLCFJS2025-11-27
10884521852631RitusMozarc Medical US LLCFJS2025-11-27
10884521852648RitusMozarc Medical US LLCFJS2025-11-27
10884521852686RitusMozarc Medical US LLCFJS2025-11-27
10884521852693RitusMozarc Medical US LLCFJS2025-11-27
10884521852709RitusMozarc Medical US LLCFJS2025-11-27
10884521852730RitusMozarc Medical US LLCFJS2025-11-27
10884521852747RitusMozarc Medical US LLCFJS2025-11-27
10884521852754RitusMozarc Medical US LLCFJS2025-11-27
10884521852761RitusMozarc Medical US LLCFJS2025-11-27
10884521852792RitusMozarc Medical US LLCFJS2025-11-27
10884521852808RitusMozarc Medical US LLCFJS2025-11-27
10884521852846RitusMozarc Medical US LLCFJS2025-11-27
10884521852853RitusMozarc Medical US LLCFJS2025-11-27
10884521852860RitusMozarc Medical US LLCFJS2025-11-27
10884521852877RitusMozarc Medical US LLCFJS2025-11-27
10884521852884RitusMozarc Medical US LLCFJS2025-11-27
20884521852898RitusMozarc Medical US LLCFJS2025-11-27
10884521852907RitusMozarc Medical US LLCFJS2025-11-27
10884521852938RitusMozarc Medical US LLCFJS2025-11-27
10884521852945RitusMozarc Medical US LLCFJS2025-11-27