DEVICE: ManoScan (07290101362685)

Device Identifier (DI) Information

ManoScan
3920
In Commercial Distribution
3920
Covidien LP
07290101362685
GS1

1
058614483 *Terms of Use
3D A300 Module
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
FFX SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K091070 000
K151086 000
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: ;
Storage Environment Temperature: between -40 and 65 Degrees Celsius
Handling Environment Temperature: between 10 and 35 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1f99f0d2-5146-461d-917e-610f41a09000
November 08, 2019
6
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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

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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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
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