FDA.report

IntelliSystem®

Primary DI
10884450021467
Brand
IntelliSystem®
Company
Merit Medical Systems, Inc.
Model
00884450021460
Published
2016-09-24
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
DXTINJECTOR AND SYRINGE, ANGIOGRAPHIC

Product Code Classifications

CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Premarket Submissions

SubmissionSupplement
K884913000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K884913000MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)Merit Medical Systems, Inc.1989-04-18DXT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450021467PackageGS15In Commercial Distribution
20884450021464PackageGS14In Commercial Distribution
00884450021460PrimaryGS10

GMDN Terms

TermDefinition
Catheter/overtube balloon inflator, single-useA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

Sterilization Methods

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 DIBrandModelCatalogPublished
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24
10884450845223Merit Medical®D3339-312026-03-24
10884450027339Merit Medical®Initial ReleaseK04-01029A2026-03-20
10884450112721Merit Medical®Initial ReleaseK09-10994G2026-03-21
20884450164918Merit Medical®Initial ReleaseK09-12174B2026-03-21
10884450428532Merit Medical®Initial ReleaseK09-09762A2026-03-21
10884450430788Merit Medical®Initial ReleaseK10-05773A2026-03-21
10884450430856Merit Medical®Initial ReleaseK09-04213A2026-03-21
10884450440602Merit Medical®Initial ReleaseK09-11433M2026-03-21
20884450441514Merit Medical®Initial ReleaseK09-14148B2026-03-21
20884450441552Merit Medical®Initial ReleaseK12-12053B2026-03-21
10884450441784SteadySheath®BLR-TSS-13.02026-03-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10884450121433Merit Medical®Merit Medical Systems, Inc.DXT2026-01-13
00616258020419MEDRAD® Mark 7 Arterion Injection SystemBayer Medical Care Inc.DXT2025-12-19
40616258021247MEDRAD® VFLOW Sterile Disposable Hand ControllerBayer Medical Care Inc.DXT2025-12-19
00616258025186MEDRAD® Stellant CT Injection SystemBayer Medical Care Inc.DXT2025-12-10
00616258027333MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationBayer Medical Care Inc.DXT2025-12-10
49345390003538MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-12-10
26938327901909DeRoyalShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-28
26938327909189Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
16938327909199Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
16938327909205Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
26945764400148AntmedShenZhen Antmed Co., LtdDXT2025-09-17
26945764400162AntmedShenZhen Antmed Co., LtdDXT2025-09-17
50628725095078MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095085MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095108MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095160MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095177MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095184MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095191MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095214MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
09345390003356MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-08-18
00628725095066MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15
50628725095153MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15
50628725095207MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15
50628725095092MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-07
50628725095115MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-07
50628725095122MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-07
50628725095139MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-07
00628725095226MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-07
50628725095238MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-07