FDA.reportPublic FDA data

Mui Scientific

Primary DI
00678467006141
Brand
Mui Scientific
Company
H & A Mui Enterprises Inc
Model
C7-BR-1007
Device description
Customized Reusable Colonic Barostat Catheter
Published
2018-08-27
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)
GBACatheter, Balloon Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFXSystem, Gastrointestinal Motility (Electrical)Gastroenterology, Urology2
GBACatheter, Balloon TypeGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973844000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973844000GASTRIC AND RECTAL CATHETERSG & J Electronics, Inc.1999-06-04FFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00678467006141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00678467006141006784670061416784670061410678467006141

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
00860014541704EnvisionSPINAL STABILIZATION TECHNOLOGIES LIMITEDGBA2026-04-30
00860014541711EnvisionSPINAL STABILIZATION TECHNOLOGIES LIMITEDGBA2026-04-30
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
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
06979032640031GOBENHUZHOU JUNDA INDUSTRY CO., LTD.GBA2025-08-26
00678467508348Mui ScientificH & A Mui Enterprises IncFFX2025-08-26
10678467508338Mui ScientificH & A Mui Enterprises IncFFX2025-08-21
00678467508331Mui ScientificH & A Mui Enterprises IncFFX2025-08-21
10884521855441ManoScanGiven Imaging, Inc.FFX2025-08-21
10678467508307Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
10678467508314Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
00678467508300Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
00678467508317Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
10678467508109Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
10678467508291Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508102Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508294Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508270Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00678467508287Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00816734023433Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023440Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023457Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16