Impedance/pH,6 imp channels,2 pH antimony,acid LPR + oes,LES locator

GUDID 08717775954095

Adult, 6.9 Fr

Medical Measurement Systems B.V.

Oesophageal motility analysis system
Primary Device ID08717775954095
NIH Device Record Key07324c25-7a0c-4512-9ea8-cb6cb35989fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameImpedance/pH,6 imp channels,2 pH antimony,acid LPR + oes,LES locator
Version Model NumberMMS-Z2L-A-LES
Company DUNS416277333
Company NameMedical Measurement Systems B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108717775954095 [Primary]
GS108717775954118 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Product Code

FFXSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-10-19
Device Publish Date2016-09-23

Devices Manufactured by Medical Measurement Systems B.V.

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00814247021229 - Flowstar2024-04-29
08717775955702 - HEM2022-11-28
08717775955870 - HEM FS2022-11-28
08720648846007 - Solar GI air-charged 4P, Compact Pole system2022-05-16 Solar GI air-charged 4P, Compact Pole system, 115V
08717775953012 - Impedance/pH, 6 imp channels, 1 pH antimony, Adult, 6.4 Fr2020-10-19

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