FDA.report

AMT Capsule Monarch® G-Tube

Primary DI
00842071111595
Brand
AMT Capsule Monarch® G-Tube
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
9-CG1210
Device description
12FR Capsule Monarch G-Tube w/ Guidewire (Box 2)
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842071111595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071111595008420711115958420711115950842071111595

GMDN Terms

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

TypeValueUnit
Catheter Gauge12French

Sterilization Methods

Method

Contacts

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

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