FDA.report

AVANOS

Primary DI
00350770456591
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
20-0966
Catalog number
20-0966
Device description
CORTRAK* Enteral Access System - Reusable Cable
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00350770456591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00350770456591003507704565913507704565910350770456591

GMDN Terms

TermDefinition
Enteral tube tracking systemA mains electricity (AC-powered) portable electronic device assembly, typically with rechargeable battery, designed to detect, record, and display an electromagnetic (EM) signal emitted from a transmitter in an enteral feeding tube stylet to facilitate the placement of the enteral tube, by providing a graphic display representing the path of the tube tip. It consists of an electromagnetic receiver placed on the epigastrium, a visual display/control unit which displays real-time anterior and cross-sectional representational views of the transmitter location and track, and a separately supplied single-use enteral feeding tube stylet which incorporates an electromagnetic transmitter in the tip.

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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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