FDA.reportPublic FDA data

Ritus

Primary DI
20884521852898
Brand
Ritus
Company
Mozarc Medical US LLC
Model
8888414029
Device description
Peritoneal Dialysis Catheter,Moncrief-Popovich Swan Neck Curl Cath, 2 Cuff,62.5 cm
Published
2025-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K862046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862046000SWAN-NECK PERITONEAL DIALYSIS CATHETERSAccurate Surgical Instruments Co.1986-06-19FJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521852898PackageGS15In Commercial Distribution
10884521852891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452185289820884521852898
1088452185289110884521852891

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal dialysis catheter, chronicA tube used to infuse a solution (dialysate) into the peritoneal cavity, allowing metabolic wastes/fluid to diffuse from the blood to the dialysate using the peritoneum as the dialysing membrane. It is usually surgically or endoscopically implanted, percutaneously, for long-term use; it may be provided with Dacron cuffs to promote tissue ingrowth for the prevention of fluid leaks and bacterial penetration. It may be used in manual continuous ambulatory peritoneal dialysis (CAPD), automated continuous cyclic peritoneal dialysis, intraperitoneal chemotherapy, or to eliminate fluid overload in congestive heart failure. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length62.5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39053529111RegulatoryOperations@mozarcmedical.com

Regulatory Flags#

DUNS number
118997146
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
false
Expiration date on label
true
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
10884521811164Ritus88155440102026-04-20
10884521811270Ritus88108050012026-04-20
10884521811287Ritus88137910012026-04-20
10884521811201Ritus88177910012024-10-21
10884521852822Argyle88884114472026-02-06
10884521005471MAHURKAR88881351662015-08-31
10884521006287MAHURKAR88881351342015-08-31
10884521006300MAHURKAR88881351352015-08-31
10884521006324MAHURKAR88881351362015-08-31
10884521006386MAHURKAR88881351632015-08-31
10884521006409MAHURKAR88881351642015-08-31
10884521006423MAHURKAR88881351652015-08-31
10884521006492MAHURKAR88881351932015-08-31
10884521006508MAHURKAR88881351942015-08-31
10884521006522MAHURKAR88881351962015-08-31
10884521006553MAHURKAR88881352432015-08-31
10884521006560MAHURKAR88881352442015-08-31
10884521070332Argyle88311730102015-10-22
10884521794733MAHURKAR88172320192020-04-12
10884521794740MAHURKAR88311730102020-04-12

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
00792079000752Peritoneal Dialysis Catheter AdapterMedionics 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
10884521852907RitusMozarc Medical US LLCFJS2025-11-27
10884521852938RitusMozarc Medical US LLCFJS2025-11-27
10884521852945RitusMozarc Medical US LLCFJS2025-11-27