FDA.reportPublic FDA data

Ameda

Primary DI
00810725025444
Brand
Ameda
Company
AMEDA, INC.
Model
HygieniKit Plus
Catalog number
17452
Published
2021-04-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHHBreast Pump Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHHBreast Pump KitObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011519000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011519000AMEDA HYGIENIKITHollister, Inc.2001-08-15HGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810725022702PackageGS112In Commercial Distribution
00810725025444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810725022702008107250227028107250227020810725022702
00810725025444008107250254448107250254440810725025444

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump support kit, single-useA collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and milk collection containers (e.g., bottle, cup). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
866-992-6332parentcare@ameda.com

Regulatory Flags#

DUNS number
078719435
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810725026168Ameda, Inc.201X09201X092025-09-09
00810725026175Ameda, Inc.201X10201X102025-09-09
00810725026182Ameda, Inc.201X11201X112025-09-09
00810725026199Ameda, Inc.201X12201X122025-09-09
00810725026205Ameda, Inc.201X13201X132025-09-09
00810725026212Ameda, Inc.201W01H201W01H2025-09-09
00810725026250Ameda, Inc.201W23201W232025-09-09
00810725025574AmedaMya Joy PLUS132A042021-07-16
00810725025581AmedaMya Joy PLUS132A052021-07-16
00810725025598AmedaMya Joy PLUS132A062021-07-16
00810725025772AmedaMya Joy PLUS132W122021-07-16
00810725025864AmedaPearl201W012023-01-19
00810725020012Ameda, Inc.17146M17146M2016-09-24
00810725020081Ameda, Inc.17170M17170M2016-09-27
00810725020104Ameda, Inc.17148PM17148PM2016-09-24
00810725020111Ameda, Inc.17358M17358M2016-09-27
00810725020524Ameda, Inc.17105171052016-09-24
00810725020579Ameda, Inc.17150171502016-09-24
00810725020586Ameda, Inc.171512016-09-24
00810725020593Ameda, Inc.17152171522016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00020451905389MedelaGuangdong Youmeng Electrical Technology Co., Ltd.OHH2026-03-20
01220000280335Motion InBra™ Double Pumping setMedela LLCOHH2026-03-10
01220000280342Motion InBra™ Single Pumping setMedela LLCOHH2026-03-10
01220000280731Motion InBra™ Double Pumping setMedela LLCOHH2026-03-10
01220000280748Motion InBra™ Single Pumping setMedela LLCOHH2026-03-10
00810104131247Wave, Collection Cups, Tubing and Diaphragm Set, RetailWILLOW INNOVATIONS, INC.OHH2026-01-28
00810104131261Wave, Collection Cups, 3pc Adapter Set, ReplacementWILLOW INNOVATIONS, INC.OHH2026-01-28
00810104130929Wave, Collection Cups KitWILLOW INNOVATIONS, INC.OHH2025-12-17
00020451472928Resupply Kit Swing Maxi/Freestyle Hands-free PumpMedela LLCOHH2025-01-17
00020451472935Resupply Kit Swing Maxi/Freestyle Hands-free PumpMedela LLCOHH2025-01-17
00020451472942Resupply Kit Swing Maxi/Freestyle Hands-free PumpMedela LLCOHH2025-01-17
00020451468723Pump In Style® Hands-free Resupply KitMedela LLCOHH2024-07-15
00020451468730Pump In Style® Hands-free Resupply KitMedela LLCOHH2024-07-15
00020451468747Pump In Style® Hands-free Resupply KitMedela LLCOHH2024-07-15
0002045146457218mm PersonalFit™ Plus Breast shieldsMedela LLCOHH2024-05-21
2002045146457618mm PersonalFit™ Plus Breast shieldsMEDELA, INC.OHH2024-05-21
1002045146456218mm PersonalFit™ Plus Breast shieldsMedela LLCOHH2024-05-21
10020451464586PNSMX Resupply kitsMedela LLCOHH2024-05-21
00020451463629Pediatric Breast Pump Kit with HarmonyMedela LLCOHH2024-05-08
00020451464473Breast Pump Kit with Harmony & 80mL containerMedela LLCOHH2024-05-08
20020451463623Pediatric Breast Pump Kit with HarmonyMEDELA, INC.OHH2024-05-08
20020451464477Breast Pump Kit with Harmony & 80mL containerMEDELA, INC.OHH2024-05-08
20020451463449Colostrum ProtectorMedela LLCOHH2023-11-01
00020451463445Colostrum ProtectorMEDELA, INC.OHH2023-11-01
00020451457833Hands-free Breast shields, 27mmMedela LLCOHH2023-10-30
20020451457837Hands-free Breast shields, 27mmMEDELA, INC.OHH2023-10-30
00020451458519PersonalFit Flex™ Double Pumping KitMedela LLCOHH2023-08-18
00020451458533PersonalFit Flex™ Double Pumping KitMedela LLCOHH2023-08-18
20020451458513PersonalFit Flex™ Double Pumping KitMEDELA, INC.OHH2023-08-18
20020451458537PersonalFit Flex™ Double Pumping KitMEDELA, INC.OHH2023-08-18