AccessGUDID - DEVICE: NeoHug® (00812594013409)

GUDID

Device Identifier (DI) Information

Brand Name: NeoHug®
Version or Model: Smiley Assorted -Suction
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N681A-S
Company Name: Neotech Products LLC

Primary DI Number: 00812594013409
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 198013435 *Terms of Use

Device Description: NeoHug is intended to support, organize or hold non-operating medical devices.

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":	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?
61952	Frame/rail/pole device holder	A clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAY	Support, Breathing Tube

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: c2d1512b-a343-4b7a-bf1c-5c62874d7546
Public Version Date: September 20, 2023
Public Version Number: 4
DI Record Publish Date: June 14, 2021