FDA.reportPublic FDA data

Tulip Size M

Primary DI
00814079020698
Brand
Tulip Size M
Company
Ardo medical AG
Model
63.00.15
Catalog number
63.00.15
Device description
Nipple Shields Size M
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00814079020698PrimaryGS10
07640109059634Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814079020698008140790206988140790206980814079020698
07640109059634076401090596347640109059634

GMDN Terms#

Term, Definition table
TermDefinition
Nipple shield, reusableA device in the form of a flexible, teat-like, dome worn by a nursing mother to cover and protect her nipples during breast feeding. It is typically made of preformed silicone materials that do not interfere with nipple stimulation; it has small holes at the distal end for milk flow. It is typically used when the nipples are sore, the infant is having latch-on problems (i.e., aberrant suckling technique), the infant is premature, ill, or small (suction inside the nipple shield holds the nipple in an extended position), or when the mother has flat or inverted nipples (it provides sensation deep in the mouth that stimulates the baby). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41417547070info@ardo.ch
+18444112736support@ardo-usa.com

Regulatory Flags#

DUNS number
481670396
Device count
200
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640108054975Ardo Melia63.00.57163.00.5712026-02-27
07640108054982Ardo Melia63.00.57163.00.5712026-02-27
07640108051080Alyssa Hands-Free to-go63.00.51363.00.5132025-09-15
07640108055507Hospital Kit DeTach 21 mm63.00.47663.00.4762025-08-27
07640108055521Hospital Kit DeTach 24 mm63.00.47763.00.4772025-08-27
07640108052506Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit Fussschalter30.00.22 / UP033C30.00.222025-07-16
07640108053374Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115V31.00.22 / UP030C31.00.222025-07-16
07640108055293Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115V30.00.24 / UP034C30.00.242025-07-16
07640108054470Alyssa Hands-Free63.00.45363.00.4532024-01-22
07640108054494Hands-Free Double Pumpset63.00.45463.00.4542024-01-22
00814079020094Amaryll63.00.19063.00.1902022-08-04
00814079020872Double Clinic Pumpset63.00.28363.00.2832016-09-22
00814079022203Double Clinic Pumpset63.00.55563.00.5552023-09-06
00814079022210Double Clinic Pumpset63.00.55563.00.5552023-09-06
07640108051516Bellis63.00.52463.00.5242023-05-24
07640108053961Alyssa to-go63.00.51163.00.5112023-05-24
00814079021862Tulips Size S63.00.2363.00.232023-05-23
00814079022104Tulips Size S63.00.32363.00.3232023-05-23
07640109059627Tulips Size S63.00.2363.00.232023-05-23
00814079022111Tulips Size S63.00.32363.00.3232023-05-23

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
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