FDA.reportPublic FDA data

Flex-Neck®

Primary DI
10884450330231
Brand
Flex-Neck®
Company
Merit Medical Systems, Inc.
Model
00884450330234
Catalog number
CF-5470/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

Product Codes#

Code, Name table
CodeName
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
FJSCatheter, peritoneal, long-term indwelling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2
FJSCatheter, Peritoneal, Long-Term IndwellingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070730000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070730000FLEX-NECK ARC CATHETERMedigroup, Inc.2007-07-03FJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450330231PackageGS130In Commercial Distribution
00884450330234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445033023110884450330231
00884450330234008844503302348844503302340884450330234

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450161692Merit Medical®Initial ReleaseK09-10791D2026-10-22
00884450428238Merit Medical®Initial ReleaseK10-00125M2026-10-22
00884450435700Merit Medical®Initial ReleaseK10-04943A2026-10-22
00884450499214Merit Medical®Initial ReleaseK12T-02975G2026-10-22
00884450501023Merit Medical®Initial ReleaseK12T-127572026-10-22
00884450501047Merit Medical®Initial ReleaseK10-06118G2026-10-22
00884450501054Merit Medical®Initial ReleaseK09-05248Q2026-10-22
00884450501078Merit Medical®Initial ReleaseK10-00389R2026-10-22
00884450501085Merit Medical®Initial ReleaseK09-14184F2026-10-22
00884450502075Merit Medical®Initial ReleaseK10-03143F2026-10-22
00884450502082Merit Medical®Initial ReleaseK12T-09122J2026-10-22
00884450502556Merit Medical®Initial ReleaseK09-144532026-10-22
00884450502891Merit Medical®Initial ReleaseK09-05181J2026-10-22
00884450502921Merit Medical®Initial ReleaseK09-12476F2026-10-22
00884450502938Merit Medical®Initial ReleaseK09-14208C2026-10-22
00884450502952Merit Medical®Initial ReleaseK09-10938F2026-10-22
00884450502969Merit Medical®Initial ReleaseK09-13923C2026-10-22
10884450485672EndoAVF® Access KitInitial ReleaseK21-000922026-10-22
00884450420065Merit Medical®Initial ReleaseK09-14003B2026-10-21
00884450431641Merit Medical®Initial ReleaseK12-11132C2026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-20
00884450104576Flex-Neck®Merit Medical Systems, Inc.FJS2026-10-16
10884450614409Prelude®Merit Medical Systems, Inc.DRE2026-10-09
00886333226931Micro-Access IntroducerARGON MEDICAL DEVICES, INC.DRE2026-10-07
00886333226948Micro-Access IntroducerARGON MEDICAL DEVICES, INC.DRE2026-10-07
10884450280055Prelude®Merit Medical Systems, Inc.DRE2026-09-29
10884450415839Prelude®Merit Medical Systems, Inc.DRE2026-09-29
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-18
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DRE2026-07-31
10884450708955Prelude®Merit Medical Systems, Inc.DRE2026-07-18
00884450846254Flex-Neck®Merit Medical Systems, Inc.FJS2026-07-08
10884450415631Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450415655Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450707781Prelude®Merit Medical Systems, Inc.DRE2026-07-08
00884450860342Merit S-MAK™Merit Medical Systems, Inc.DRE2026-06-25
00884450468340Merit MAK™Merit Medical Systems, Inc.DRE2026-06-23
10884450706708Prelude®Merit Medical Systems, Inc.DRE2026-06-03
10884450415358Prelude®Merit Medical Systems, Inc.DRE2026-05-28
00685447020264VersaCross Connect™ Transseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
00685447020271VersaCross Connect™ Transseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
00685447020288VersaCross™ Large Access Trasseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
00685447020295VersaCross™ Large Access Trasseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
04251244502768Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244502775Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244502782Catapult Guide SheathContract Medical International GmbHDRE2024-08-19
04251244501983Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244501990Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502003Catapult Guide SheathContract Medical International GmbHDRE2023-09-01
04251244502010Catapult Guide SheathContract Medical International GmbHDRE2023-09-01