FDA.reportPublic FDA data

AMT Capsule Monarch® G-Tube

Primary DI
00842071116644
Brand
AMT Capsule Monarch® G-Tube
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
9-CG2010
Catalog number
9-CG2010
Device description
20FR Capsule Monarch G-Tube w/ Guidewire (Boxed 1)
Published
2017-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071116644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071116644008420711166448420711166440842071116644

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy tubeA thin, flexible, hollow tube intended to be percutaneously inserted into the stomach, typically through puncture of the abdominal wall and stomach after distention of the stomach by endoscopic methods. It is intended to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Additional disposable enteral feeding components (e.g., external tubing, syringe) may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge20French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(440) 717-4000cs@appliedmedical.net

Regulatory Flags#

DUNS number
038101861
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071153038AMT MiniONE Extension SetE8-1255-ISOSAFE8-1255-ISOSAF, 8-1255-ISOSAF2026-03-23
00842071149932MiniSPC ButtonSPC-1408-12SPC-1408-122026-03-16
00842071149949MiniSPC ButtonSPC-1408-24SPC-1408-242026-03-16
00842071149956MiniSPC ButtonSPC-1410-12SPC-1410-122026-03-16
00842071149963MiniSPC ButtonSPC-14100-12SPC-14100-122026-03-16
00842071149970MiniSPC ButtonSPC-14100-24SPC-14100-242026-03-16
00842071149987MiniSPC ButtonSPC-1410-24SPC-1410-242026-03-16
00842071149994MiniSPC ButtonSPC-1412-12SPC-1412-122026-03-16
00842071150006MiniSPC ButtonSPC-1412-24SPC-1412-242026-03-16
00842071150013MiniSPC ButtonSPC-1415-12SPC-1415-122026-03-16
00842071150020MiniSPC ButtonSPC-1415-24SPC-1415-242026-03-16
00842071150037MiniSPC ButtonSPC-1417-12SPC-1417-122026-03-16
00842071150044MiniSPC ButtonSPC-1417-24SPC-1417-242026-03-16
00842071150051MiniSPC ButtonSPC-1420-12SPC-1420-122026-03-16
00842071150068MiniSPC ButtonSPC-1420-24SPC-1420-242026-03-16
00842071150075MiniSPC ButtonSPC-1423-12SPC-1423-122026-03-16
00842071150082MiniSPC ButtonSPC-1423-24SPC-1423-242026-03-16
00842071150099MiniSPC ButtonSPC-1425-12SPC-1425-122026-03-16
00842071150105MiniSPC ButtonSPC-1425-24SPC-1425-242026-03-16
00842071150112MiniSPC ButtonSPC-1427-12SPC-1427-122026-03-16

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Primary DI, Brand, Company table
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00842071146412MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-02-13
00842071146429MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-02-13
00816340023162Transfer StrawNEODEVICES INCKNT2026-02-05
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