AccessGUDID - DEVICE: Avaline Medical NJ LLC (00810077211816)

GUDID

Device Identifier (DI) Information

Brand Name: Avaline Medical NJ LLC
Version or Model: ZRUP3654Rx1+st
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ZRUP3654Rx1+st
Company Name: Avaline Medical NJ Limited Liability Company

Primary DI Number: 00810077211816
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079767953 *Terms of Use

Device Description: Washable Underpads 36"x54" x1

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?
66117	Absorbent underpad, non-antimicrobial, reusable	A flat piece of absorbent fabric material (e.g., polyester, cotton) intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids (typically urine associated with bladder weakness/incontinence); it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EYQ	GARMENT, PROTECTIVE, FOR INCONTINENCE

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: f2baff1e-cb4a-4563-8d66-80a36a8606e5
Public Version Date: June 20, 2023
Public Version Number: 3
DI Record Publish Date: December 03, 2021