FDA.reportPublic FDA data

FastBreak™

Primary DI
00884450316993
Brand
FastBreak™
Company
Merit Medical Systems, Inc.
Model
00884450316993
Published
2017-10-16
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
GBXCATHETER, IRRIGATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450316993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450316993008844503169938844503169930884450316993

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose catheter connector, sterileA small sterile device intended to create a mechanical union between a catheter and an external device (non-dedicated) typically via a Luer connection; it has an intended use profile that is not dedicated to a specific type of catheter (i.e., can be applied to catheters specific to different anatomical sites and body fluids). It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450031469Merit Medical®Initial ReleaseK09-02709B2026-10-07
00884450554883SCOUT®MSG-022026-10-07
00884450836316Performa®D7445-B72026-10-07
00884450376713Merit Medical®Initial ReleaseK09-08747L2026-10-06
00884450428344Merit Medical®Initial ReleaseK11-01422A2026-10-06
10884450438791Prelude® Short SheathBPSS-8F-4-018MT2026-10-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M640R99000990021Ch24 round silicone catheterRAND SPAGBX2026-09-22
00884450022146One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022160One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022184One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022306One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022313One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022535One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022559One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022566One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022573One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022597One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022603One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022665One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022689One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450022764One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450024010One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00884450024027One-Step™Merit Medical Systems, Inc.GBX2026-07-29
00840456202692JMUJMU DENTAL, INCGBX2026-07-27
00840456202708JMUJMU DENTAL, INCGBX2026-07-27
00884450014523ReSolve®, StayFIX®,Merit Medical Systems, Inc.GBX2026-07-16
00840456216750JMUJMU DENTAL, INCGBX2026-06-22
00840456216767JMUJMU DENTAL, INCGBX2026-06-22
00840456216774JMUJMU DENTAL, INCGBX2026-06-22
17350128050006LinkUS DrainInterlinked ABGBX2026-05-31
10080196995998MEDLINEMEDLINE INDUSTRIES, INC.GBX2024-12-12
10080196128839MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
10080196997633MedlineMEDLINE INDUSTRIES, INC.GBX2023-12-27
08034139292823Thoracic Catheter, Straight Fr 18REDAX SPAGBX2021-05-07
08034139292830Thoracic Catheter, Straight Fr 21REDAX SPAGBX2021-05-07
08034139292847Thoracic Catheter, Straight Fr 24REDAX SPAGBX2021-05-07