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Mui Scientific

FDA UDI

Class II (US FDA UDI)

by H & A Mui Enterprises Inc

Identity

Trade Name
Mui Scientific FDA UDI
Generic Name
Gastrointestinal motility manometric catheter, non-electronic FDA UDI
Device Name
Replacement Barostat Balloon (Pillow-Type) - 800mL Gastric FDA UDI
Model / Reference
CT-BP800G FDA UDI
Description
Replacement Barostat Balloon (Pillow-Type) - 800mL Gastric FDA UDI

Identifiers

Primary DI / UDI-DI
00678467000835 FDA UDI
510(k) Number
K973844 FDA UDI
FDA Product Code
FFX FDA UDI
GMDN Term
Gastrointestinal motility manometric catheter, non-electronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1725 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Mui Scientific by H & A Mui Enterprises Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K973844 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
H & A Mui Enterprises Inc

Sources (1)

  • FDA UDI faab1712-33b8-482c-8487-73d39ae818e4 36 fields · synced May 31, 2026