DEVICE: Capsule Monarch® Gastrostomy Tube (00842071103873)

Device Identifier (DI) Information

Capsule Monarch® Gastrostomy Tube
E9-C1810
In Commercial Distribution
E9-C1810
APPLIED MEDICAL TECHNOLOGY, INC.
00842071103873
GS1

1
038101861 *Terms of Use
18FR Capsule Monarch Gastrostomy Tube (Pouched)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
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
Gastrostomy tube A sterile, thin, flexible, hollow cylinder percutaneously inserted into the stomach, typically through puncture of the abdominal wall and stomach after distention of the stomach by endoscopic methods. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and/or to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
KNT Tubes, Gastrointestinal (And Accessories)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 18 French
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Device Record Status

4fa9d58b-5783-46a9-b94e-05b8fd5b342f
March 29, 2018
2
August 31, 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
00842071106027 2 00842071103873 2017-03-06 Not in Commercial Distribution Box (9-C1810)
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
(440)717-4000
cs@appliedmedical.net
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