AccessGUDID - DEVICE: Avaline Medical NJ LLC (00810124534370)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00810124534370
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 288
Labeler D-U-N-S® Number*: 079767953 *Terms of Use

Device Description: Maternity Pads with tails

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):	Yes
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?
40545	Menstrual pad, unscented	A non-deodorized, feminine hygiene product (a pad) that is held in place externally to absorb menstrual or other vaginal discharge. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHD	Pad, menstrual, unscented

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: 60cb21a1-45f9-4986-a1ea-a8bc25c8644e
Public Version Date: March 03, 2025
Public Version Number: 1
DI Record Publish Date: February 22, 2025