FDA.reportPublic FDA data

Flex-Neck®

Primary DI
00884450375006
Brand
Flex-Neck®
Company
Merit Medical Systems, Inc.
Model
00884450375006
Catalog number
CF-4235/D
Published
2018-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450375003PackageGS11In Commercial Distribution
20884450375000PackageGS130In Commercial Distribution
00884450375006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445037500310884450375003
2088445037500020884450375000
00884450375006008844503750068844503750060884450375006

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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450029756Merit Medical®Initial ReleaseK08-02280A2026-09-29
00884450421383Merit Medical®Initial ReleaseK09-09424A2026-09-29
00884450431917Merit Medical®Initial ReleaseK09-13874B2026-09-29
00884450436004Merit Medical®Initial ReleaseK12-05438A2026-09-29
00884450452974MAK-NV™DMAK-NV-0082026-09-29
00884450453339MAK-NV™DMAK-NV-0162026-09-29
00884450500002Merit Medical®Initial ReleaseK09-144152026-09-29
10884450119751Prelude EASE™JPHR6F11018SC2026-09-29
10884450280055Prelude®JPSI-4F-11-0182026-09-29
10884450415839Prelude®JPSI-7F-11-0182026-09-29
10884450439163Prelude IDeal™JPID6F11021SSC2026-09-29
10884450439187Prelude IDeal™JPID6F11021PW2026-09-29
10884450452353STAR™FRF-0510L-012026-09-29
10884450831547Tru-Cut®C2N2712X2026-09-29
00884450376867Merit Medical®Initial ReleaseK09-10502F2026-09-26
00884450431597Merit Medical®Initial ReleaseK09-12862A2026-09-26
00884450432105Merit Medical®Initial ReleaseK09-08926B2026-09-26
00884450707104Merit Medical®DTS1202026-09-26
00884450707111Merit Medical®DTS2202026-09-26
00884450028605Merit Medical®Initial ReleaseK08-01254A2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450846254Flex-Neck®Merit Medical Systems, Inc.FJS2026-07-08
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
20884521852898RitusMozarc Medical US LLCFJS2025-11-27
10884521852907RitusMozarc Medical US LLCFJS2025-11-27