FDA.reportPublic FDA data

Paruu

Primary DI
06978707520104
Brand
Paruu
Company
Linhejiacheng (Shenzhen) E-commerce Co., Ltd.
Model
NS100, 65mm
Published
2026-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HFSShield, Nipple

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFSShield, NippleGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06978707520104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978707520104069787075201046978707520104

GMDN Terms#

Term, Definition table
TermDefinition
Nipple pad/ring, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
617146719
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978707520081ParuuNS100, 45mm2026-03-11
06978707520098ParuuNS100, 55mm2026-03-11
06978707520111ParuuNP01, 20mm2026-03-11
06978707520128ParuuNP01, 24mm2026-03-11
06978707520029ParuuP162025-12-11
06978707520036ParuuP202025-12-11
06978707520043ParuuP202025-12-11
06978707520050ParuuP162025-12-11
06978707520067ParuuP102025-12-11
06978707520074ParuuP102025-12-11
06978707520012ParuuP202025-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978707520081ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
06978707520098ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
06978707520111ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
06978707520128ParuuLinhejiacheng (Shenzhen) E-commerce Co., Ltd.HFS2026-03-11
00735282286810MunchkinMUNCHKIN, INC.HFS2025-02-12
10735282286817MunchkinMUNCHKIN, INC.HFS2025-02-12
09420060202021Silicone Nipple Shields (2pcs)THINK GREEN LIMITEDHFS2024-12-17
09420060202069Breastfeeding Nipple Shield - Orthodontic Teat (Triangle Base)THINK GREEN LIMITEDHFS2024-12-17
09420060202076Breastfeeding Nipple Shield - Orthodontic Teat (Round Base)THINK GREEN LIMITEDHFS2024-12-17
09420060202083BreastFeeding Nipple Shield - Butterfly ShapeTHINK GREEN LIMITEDHFS2024-12-17
09420060202090Flexi Silicone Nipple ShieldsTHINK GREEN LIMITEDHFS2024-12-17
09420060202038Ultra-Thin Silicone Nipple Shields - LTHINK GREEN LIMITEDHFS2024-12-16
09420060202045Ultra-Thin Silicone Nipple Shields - MTHINK GREEN LIMITEDHFS2024-12-16
09420060202052 Breastfeeding Nipple Shield - Round BaseTHINK GREEN LIMITEDHFS2024-12-16
09420060202014Silicone Nipple Shields (2pcs)THINK GREEN LIMITEDHFS2024-12-12
00735282281310MunchkinMUNCHKIN, INC.HFS2024-11-14
00735282281327MunchkinMUNCHKIN, INC.HFS2024-11-14
00735282281334MunchkinMUNCHKIN, INC.HFS2024-11-14
00735282281358MunchkinMUNCHKIN, INC.HFS2024-11-14
10735282281317MunchkinMUNCHKIN, INC.HFS2024-11-14
10735282281324MunchkinMUNCHKIN, INC.HFS2024-11-14
10735282281331MunchkinMUNCHKIN, INC.HFS2024-11-14
10735282281355MunchkinMUNCHKIN, INC.HFS2024-11-14
00735282383236MunchkinMUNCHKIN, INC.HFS2024-06-25
00735282383243MunchkinMUNCHKIN, INC.HFS2024-06-25
00735282383984MunchkinMUNCHKIN, INC.HFS2024-06-25
00735282383991MunchkinMUNCHKIN, INC.HFS2024-06-25
10735282383233MunchkinMUNCHKIN, INC.HFS2024-06-25
10735282383240MunchkinMUNCHKIN, INC.HFS2024-06-25
10735282383981MunchkinMUNCHKIN, INC.HFS2024-06-25