AccessGUDID - DEVICE: AVANOS (00350770466453)

GUDID

Device Identifier (DI) Information

Brand Name: AVANOS
Version or Model: 20-2438AIV2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-2438AIV2
Company Name: Avanos Medical, Inc.

Primary DI Number: 00350770466453
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: CORFLO* Nasogastric/Nasointestinal Feeding Tube with Stylet with ANTI-IV* Connector

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14221	Nasogastric feeding tube	A sterile, thin, flexible, hollow cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily for enteral feeding and the administration of medications, either by gravity or with a pump; it may also be used for aspiration of gastric contents (e.g., gastric secretions). It is typically a single lumen, rubber or plastic tube of various diameters (typically smaller than those of nasogastric tubes intended primarily for decompression) with circular markings that serve as insertion guides. It is frequently used for very ill or comatose patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPD	TUBE, FEEDING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 8 Centimeter

Device Record Status

Public Device Record Key: 50e9ee7a-59f7-4ce7-b47e-d5efcd706406
Public Version Date: August 17, 2020
Public Version Number: 1
DI Record Publish Date: August 07, 2020