FDA.reportPublic FDA data

Mui Scientific

Primary DI
00678467505248
Brand
Mui Scientific
Company
H & A Mui Enterprises Inc
Model
CE4-1223
Device description
16Ch Cust. Reusable Esophageal Catheter
Published
2018-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFXSystem, Gastrointestinal Motility (Electrical)
KLAMonitor, Esophageal Motility, And Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFXSystem, Gastrointestinal Motility (Electrical)Gastroenterology, Urology2
KLAMonitor, Esophageal Motility, Anorectal Motility, And TubeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983665000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983665000MANOMETRIC ASSEMBLIESDentsleeve Pty., Ltd.1999-05-17KLA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00678467505248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00678467505248006784675052486784675052480678467505248

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal manometric catheter, non-electronicA non-sterile, non-electrical flexible tube intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract for measuring pressure to assess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal musculature and anal sphincter functions, typically in the evaluation of GI disorders [e.g., gastro-oesophageal reflux disease (GERD), faecal incontinence]. It functions via infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in/connected to a dedicated analysis system. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9058905525mail@muiscientific.com

Regulatory Flags#

DUNS number
243872611
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10678467508437Mui ScientificS7-E22-10042026-04-15
00678467000422Mui ScientificR8B-3-0-0-0-0-0-0-02016-09-23
00678467000446Mui ScientificR8B-3-.5-.5-.5-.5-.5-.5-.52016-09-23
10678467508246Mui ScientificS7-E16-10262025-04-10
10678467508253Mui ScientificS7-R8-10572025-04-15
10678467508345Mui ScientificS7-R24-10442025-08-26
00678467000705Mui ScientificSPE4-3-3-32016-09-23
00678467000712Mui ScientificSPE4-5-5-52016-09-23
00678467503978Mui ScientificCE4-11902019-09-05
00678467504098Mui Scientific CE4-11372019-09-05
00678467504142Mui Scientific CR4-10872019-09-05
00678467504203Mui Scientific CR4-10882019-09-05
00678467504227Mui Scientific CR5-10282019-09-05
00678467504258Mui Scientific CE5-10762019-09-05
00678467504272Mui Scientific CE4-11952019-09-05
00678467505330Mui Scientific CE4-12512019-09-05
00678467502865Mui ScientificCE5-00452019-06-13
00678467503145Mui ScientificCE4-00352019-06-13
00678467502414Mui ScientificCE4-10742019-06-12
00678467500694Mui ScientificCE1-A-E57-OSH-22016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10678467508437Mui ScientificH & A Mui Enterprises IncFFX2026-04-15
10678467508413Mui ScientificH & A Mui Enterprises IncFFX2026-01-23
00678467508416Mui ScientificH & A Mui Enterprises IncFFX2026-01-23
00851607003501mcompass Anorectal Balloon Expulsion CatheterMEDSPIRA, LLCFFX2025-12-30
00678467508409Mui ScientificH & A Mui Enterprises IncKLA2025-11-17
00678467508393Mui ScientificH & A Mui Enterprises IncFFX2025-11-04
00678467508386Mui ScientificH & A Mui Enterprises IncFFX2025-10-21
00678467508362Mui ScientificH & A Mui Enterprises IncFFX2025-09-15
10678467508352Mui ScientificH & A Mui Enterprises IncFFX2025-08-28
00678467508355Mui ScientificH & A Mui Enterprises IncFFX2025-08-28
10678467508345Mui ScientificH & A Mui Enterprises IncFFX2025-08-26
10678467508338Mui ScientificH & A Mui Enterprises IncFFX2025-08-21
10678467508307Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
10678467508314Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
10678467508109Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
10678467508291Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
10678467508253Mui ScientificH & A Mui Enterprises IncFFX2025-04-15
10678467508239Mui ScientificH & A Mui Enterprises IncFFX2025-04-10
10678467508246Mui ScientificH & A Mui Enterprises IncFFX2025-04-10
00851607003006QuikLinq FOB Adapter MEDSPIRA, LLCKLA2025-03-10
00627825014830SOLAR Anorectal Manometry CatheterLaborie Medical Technologies Corp.KLA2025-03-06
008516070035325-Pack, Luer-Locking, 100cc SyringeMEDSPIRA, LLCKLA2025-03-03
18717775956614MPP-PlusMedical Measurement Systems B.V.FFX2025-02-21
68051887046715THD Procto Software SystemTHD SPAKLA2025-02-20
B960RED201REDNeuraxis, Inc.FFX2025-01-09
008516070035185-Pack, 100 cc Syringe, Luer-lockingMEDSPIRA, LLCKLA2024-12-20
00851607003389System Accessory KitMEDSPIRA, LLCKLA2024-11-30
10678467507508Mui ScientificH & A Mui Enterprises IncFFX2024-01-24
68051887043295THD Procto Software SystemTHD SPAKLA2023-12-14
68051887043301THD Procto Software SystemTHD SPAKLA2023-12-14