FDA.reportPublic FDA data

O-Cal-ette

Primary DI
00308130099001
Brand
O-Cal-ette
Company
PHARMICS, INC.
Model
9900
Catalog number
009900
Device description
Nursing Cup
Published
2018-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00308130099001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00308130099001003081300990013081300990010308130099001

GMDN Terms#

Term, Definition table
TermDefinition
Nipple pad/ringA non-sterile device intended to be worn over/around the breast/nipple of a nursing woman between breast feedings to help protect the nipple from chafing and/or to treat sore/cracked nipples. It may be in the form of dome-shaped cover or a ring. It is normally available [non-prescription] over-the-counter (OTC). This is a reusable device after appropriate cleaning.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.38Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(801)966-4138pb@pharmics.com

Regulatory Flags#

DUNS number
058560996
Device count
1
Premarket exempt
true
Manufacturing date on label
true

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
06978707520104ParuuLinhejiacheng (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