DEVICE: EndoFLIP (05391530810012)

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Device Record History
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Device Identifier (DI) Information
EndoFLIP
EF-322N
In Commercial Distribution

Covidien LP
05391530810012
GS1

1
058614483 *Terms of Use
ENDO CATHETER EF-322N 16CM NASAL TIP
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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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35053 Manometric gastrointestinal motility analysis system
An assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.
Active false
45569 Gastrointestinal barostat
A computerized pneumatic device designed to measure tension-sensory threshold and motility in the gastrointestinal tract during neurogastroenterology assessment. It maintains a preselected pressure in an intragastric bag (balloon) of a dedicated catheter that is inserted into the gastrointestinal tract (e.g., oesophagus, stomach, intestines, rectum) and registers the pressure changes of the air pumped into the balloon at a predetermined speed (internal pressure data), and simultaneously measures the volume of air that has been used. The collected data can be used in the diagnosis of gastrointestinal disorders such as dysphagia, nausea, vomiting, anorexia, bulimia, or constipation.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FFX System, Gastrointestinal Motility (Electrical)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
bb52ca1b-06df-4de0-a1df-3bf98b88e97f
April 03, 2024
9
August 02, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05391530810074 5 05391530810012 In Commercial Distribution PACK_OR_INNER_PACK
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)261-8000
covidien.udi@covidien.com
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