FDA.report

AVANOS

Primary DI
00350770948218
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
94821
Catalog number
0112-20
Device description
* MIC* Gastrostomy Feeding Tube
Published
2019-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
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
00350770948218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00350770948218003507709482183507709482180350770948218

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 Gauge20French

Sterilization Methods

Method

Contacts

PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags

DUNS number
079375431
Device count
1
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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