Home GUDID 00081010413073
Gel Pack
Primary DI 00081010413073
Brand Gel Pack
Company EXPLORAMED NC7, INC.
Model GP2312
Device description Gel Nipple Pads (900-00135)
Published 2024-02-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name NTC Nursing Pad, Hydrogel
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NTC Nursing Pad, Hydrogel General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00081010413073 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00081010413073 00081010413073 081010413073 0081010413073
GMDN Terms# Term, Definition table Term Definition Nipple pad/ring, single-use A device intended to be worn directly over the breast/nipple of a nursing woman between breast feedings to help protect the nipple from chafing, due to friction from clothing, and/or to treat sore/cracked nipples; it may also be intended to absorb leaking breast milk. It may be in the form of a fabric or cotton pad (commonly known as a nursing pad), a dome-shaped gel (e.g., hydrogel) cover, or a ring. This is a single-use device.
Regulatory Flags# DUNS number 050917861 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04719745091568 Ameda ComfortGel Hydrogel Pads BENQ MATERIALS CORP. NTC 2025-01-21 06975983272505 Momcozy Shenzhen Lutejiacheng Supply Chain Management Co., Ltd. NTC 2024-05-23 06975983272512 Momcozy Shenzhen Lutejiacheng Supply Chain Management Co., Ltd. NTC 2024-05-23 00810104130738 Gel Pack WILLOW INNOVATIONS, INC. NTC 2024-02-14 06975983272031 Momcozy Shenzhen Lutejiacheng Supply Chain Management Co., Ltd. NTC 2023-11-08 05010058088832 Instrapac ROBINSON HEALTHCARE LIMITED NTC 2023-08-08 05010058188839 Instrapac ROBINSON HEALTHCARE LIMITED NTC 2023-08-08