FDA.reportPublic FDA data

Mui Scientific

Primary DI
10678467507065
Brand
Mui Scientific
Company
H & A Mui Enterprises Inc
Model
PC-SEI4
Device description
PatCom Single Use Introducer (ID:4.0mm OD:5.0mm)
Published
2020-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192691000PatCom Single-Use IntroducerH&A Mui Enterprises, Inc.2020-02-21FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10678467507065PrimaryGS10
00678467507068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067846750706510678467507065
00678467507068006784675070686784675070680678467507068

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal motility manometric catheter, non-electronicA 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.

Contacts#

Phone, Email table
PhoneEmail
905-890-5525mail@muiscientific.com

Regulatory Flags#

DUNS number
243872611
Device count
10
Lot or batch
true
Manufacturing date on label
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

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06936345104568Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104575Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
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