Flex-Neck®

Primary DI
10884450170028
Brand
Flex-Neck®
Company
Merit Medical Systems, Inc.
Model
00884450170021
Catalog number
CC-2300/A
Published
2015-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FKOCATHETER, PERITONEAL DIALYSIS, SINGLE USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKOCatheter, Peritoneal Dialysis, Single UseGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974570000PERITONEAL DIALYSIS CATHETER CONNECTORMedigroup, Inc.1998-02-27FKO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450170028PackageGS11In Commercial Distribution
20884450170025PackageGS160In Commercial Distribution
00884450170021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445017002810884450170028
2088445017002520884450170025
00884450170021008844501700218844501700210884450170021

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

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
00884450424087Merit Medical®Initial ReleaseK09-13251A2026-06-02
00884450431009Merit Medical®Initial ReleaseK08-03026A2026-06-02
00884450435403Merit Medical®Initial ReleaseK09-11196A2026-06-02
00884450457511C2 CryoBalloon™AFG-10242026-06-02
00884450457528C2 CryoBalloon™AFG-10282026-06-02
00884450457566C2 CryoBalloon™AFG-10552026-06-02
00884450457573C2 CryoBalloon™AFG-10562026-06-02
00884450467183Merit Medical®Initial ReleaseK10T-06193A2026-06-02
00884450474549Merit Medical®Initial ReleaseK09-134782026-06-02
00884450474556Merit Medical®Initial ReleaseK09-134792026-06-02
00884450474563Merit Medical®Initial ReleaseK09-136162026-06-02
00884450589977SplashWire™Initial ReleaseMSWSTFA35150LT2026-06-02
00884450794760DuraMax®AH7871030290412026-06-02
00884450376478Merit Medical®Initial ReleaseK09-01002L2026-05-29
00884450425374Merit Medical®Initial ReleaseK11-01298A2026-05-30
00884450429648Merit Medical®Initial ReleaseK09-13991A2026-05-29
00884450474570Merit Medical®Initial ReleaseK12T-127132026-05-29
00884450826492Fountain®AIS4-90-202026-05-29
10884450587727PowerCURVE®CPWR-2011L2026-05-30
00884450031131Merit Medical®Initial ReleaseK08-02653A2026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521811164RitusMozarc Medical US LLCFKO2026-04-20
10885403108327n/aCAREFUSION 2200, INCFKO2017-06-12
50885403108325n/aCAREFUSION 2200, INCFKO2017-06-12
10884521024281ArgyleMozarc Medical US LLCFKO2016-09-24
10884521024298ArgyleMozarc Medical US LLCFKO2016-09-24
10884521024311ArgyleMozarc Medical US LLCFKO2016-09-24
20884521024288ArgyleCovidien LPFKO2016-09-24
20884521024295ArgyleCovidien LPFKO2016-09-24
20884521024301ArgyleCovidien LPFKO2016-09-24
20884521024318ArgyleCovidien LPFKO2016-09-24
H67140005070DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005170DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005270DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005370DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005470DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005570DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
H67140005670DIALY-NATEUTAH MEDICAL PRODUCTS, INC.FKO2016-09-23
00898021000068Alcavis 50Angelini Pharma Inc.FKO2016-08-29
20898021000062Alcavis 50ANGELINI PHARMA INC.FKO2016-08-29
00884450170021Flex-Neck®Merit Medical Systems, Inc.FKO2015-10-30
00852250006017Lifemed Acute Tenckhoff Peritoneal CatheterLIFEMED OF CALIFORNIAFKO2015-10-06
10852250006014Lifemed Acute Tenckhoff Peritoneal CatheterLIFEMED OF CALIFORNIAFKO2015-10-06
00852250006079Lifemed Pediatric Acute Tenckhoff Peritoneal CatheterLIFEMED OF CALIFORNIAFKO2015-10-06