AccessGUDID - DEVICE: Halyard (30885632417119)

GUDID

Device Identifier (DI) Information

Brand Name: Halyard
Version or Model: 55569
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 30885632417119
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Nasogastric Tube Fastener Adult Skin-Friendly Adhesive 6x8cm NonWoven Fabric Beige Wrap-around Tube Securement Tab CA/2000 Not made with Natural Rubber Latex Halyard

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	Yes
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?
36053	Nasogastric tube holder, noninvasive	A small, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient. It is typically designed as an adhesive plaster with wings that are attached to the face (e.g., across the bridge of the nose, on the cheeks). It may have a lock-ring or non-adhesive tabs that is/are attached to the nasogastric tube (placed through a nostril and via the oesophagus) to hold it safely and comfortably in place. The lock-ring or tabs can be removed without scissors for easy removal of the tube. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape and bandage, adhesive

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: e321d064-f524-48c5-8aea-9ab2471e74ab
Public Version Date: October 23, 2024
Public Version Number: 2
DI Record Publish Date: July 29, 2024