FDA.report

Flex-Neck®

Primary DI
10884450330156
Brand
Flex-Neck®
Company
Merit Medical Systems, Inc.
Model
00884450330159
Catalog number
CF-5250/C
Published
2017-10-16
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

Related Records

Product Codes

CodeName
FJSCatheter, peritoneal, long-term indwelling

Product Code Classifications

CodeDeviceSpecialtyClass
FJSCatheter, Peritoneal, Long-Term IndwellingGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K970159000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K970159000FLEX-NECK PD CATHETERJanin Group, Inc.1997-09-05FJS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450330156PackageGS11In Commercial Distribution
20884450330153PackageGS130In Commercial Distribution
00884450330159PrimaryGS10

GMDN Terms

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.

Device Sizes

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

Sterilization Methods

Method

Regulatory Flags

DUNS number
184763290
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

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10884450112721Merit Medical®Initial ReleaseK09-10994G2026-03-21
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10884450428532Merit Medical®Initial ReleaseK09-09762A2026-03-21
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10884450440602Merit Medical®Initial ReleaseK09-11433M2026-03-21
20884450441514Merit Medical®Initial ReleaseK09-14148B2026-03-21
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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
10884450104689Flex-Neck®Merit Medical Systems, Inc.FJS2025-12-03
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
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