FDA.report

Gastrostomy Tube, 3 port, 14fr, ENFit

Primary DI
00616784511238
Brand
Gastrostomy Tube, 3 port, 14fr, ENFit
Company
DYNAREX CORPORATION
Model
5112
Published
2019-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications

CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784511238PrimaryGS10
00616784511214Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784511238006167845112386167845112380616784511238
00616784511214006167845112146167845112140616784511214

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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