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
CodeName
NTCNursing Pad, Hydrogel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTCNursing Pad, HydrogelGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00081010413073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00081010413073000810104130730810104130730081010413073

GMDN Terms#

Term, Definition table
TermDefinition
Nipple pad/ring, single-useA 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.

Sterilization Methods#

Method table
Method

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 DIBrandCompanyProduct codePublished
04719745091568Ameda ComfortGel Hydrogel PadsBENQ MATERIALS CORP.NTC2025-01-21
06975983272505MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.NTC2024-05-23
06975983272512MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.NTC2024-05-23
00810104130738Gel PackWILLOW INNOVATIONS, INC.NTC2024-02-14
06975983272031MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.NTC2023-11-08
05010058088832InstrapacROBINSON HEALTHCARE LIMITEDNTC2023-08-08
05010058188839InstrapacROBINSON HEALTHCARE LIMITEDNTC2023-08-08