DEVICE: Mediplus (05055140701114)
Device Identifier (DI) Information
Mediplus
2244-1E
In Commercial Distribution
MEDIPLUS LTD
2244-1E
In Commercial Distribution
MEDIPLUS LTD
8 channel oesophageal catheter, 3.9mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
17745 | Gastrointestinal motility manometric catheter, non-electronic |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KLA | MONITOR, ESOPHAGEAL MOTILITY, AND TUBE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K013704 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 150.0 Centimeter |
Outer Diameter: 3.9 Millimeter |
Device Record Status
c4e2292e-e5b1-4907-948d-530ba2cf5428
August 05, 2022
4
September 16, 2016
August 05, 2022
4
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
15055140701111 | 5 | 05055140701114 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4401494551200
help@mediplus.co.uk
help@mediplus.co.uk