FDA.reportPublic FDA data

Ameda, Inc.

Primary DI
00810725020739
Brand
Ameda, Inc.
Company
AMEDA, INC.
Model
17093
Catalog number
17093
Device description
One-Hand Pump w/ Flange Inserts
Published
2016-09-24
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
HGYPump, Breast, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGYPump, Breast, Non-PoweredObstetrics/Gynecology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912355000MOTHERS TOUCH ONE HAND BREAST PUMPHollister, Inc.1993-12-10HGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810725020736PackageGS110In Commercial Distribution
00810725020739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081072502073610810725020736
00810725020739008107250207398107250207390810725020739

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, manualA hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity55 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Fahrenheit130 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
078719435
Device count
1
Lot or batch
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
08809108019097SpectraUZINMEDICARE CO.,LTDHGY2025-10-15
00810104130936 Wave Single Manual Pump KitWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130950Wave, Container 5oz, ReplacementWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130967Wave, Gasket, 2 pack, RetailWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130974Wave, Flapper Valves, 4 pack, RetailWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130981Wave, Flange 24mm, ReplacementWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130998Wave, Single, Tubing Set, RetailWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104131001Wave, Handle, ReplacementWILLOW INNOVATIONS, INC.HGY2025-07-23
00194346442294PARENT’S CHOICEWAL-MART STORES, INC.HGY2025-05-12
00810104130790Silicone Wearable Breast PumpWILLOW INNOVATIONS, INC.HGY2025-04-28
09420060214017New Mum Premium Pack - Grey CapTHINK GREEN LIMITEDHGY2024-12-17
09420060214024New Mum Breastfeeding Essentials Pack - Grey CapTHINK GREEN LIMITEDHGY2024-12-17
09420060214031Gen. 2 Silicone Leakproof Pump & Ladybug Milk Collector Combo - 100ml Gen. 2 + 7THINK GREEN LIMITEDHGY2024-12-17
09420060214048Gen. 2 Silicone Leakproof Pump & Ladybug Milk Collector Combo - 150ml Gen. 2 + 7THINK GREEN LIMITEDHGY2024-12-17
09420060214109Silicone Pump & Milk Collector New Baby ComboTHINK GREEN LIMITEDHGY2024-12-17
09420060201581Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - Pea GreenTHINK GREEN LIMITEDHGY2024-12-16
09420060201598Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - OatTHINK GREEN LIMITEDHGY2024-12-16
09420060201604Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - ApricotTHINK GREEN LIMITEDHGY2024-12-16
09420060201611Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - LavenderTHINK GREEN LIMITEDHGY2024-12-16
09420060201628Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - BlushTHINK GREEN LIMITEDHGY2024-12-16
09420060201635Gen. 2 Silicone Breast Pump & Flower Stopper Set - 150ml - Pea GreenTHINK GREEN LIMITEDHGY2024-12-16
09420060201642Gen. 2 Silicone Breast Pump & Flower Stopper Set - 150ml - OatTHINK GREEN LIMITEDHGY2024-12-16
09420060201659Gen. 2 Silicone Breast Pump & Flower Stopper Set - 150ml - ApricotTHINK GREEN LIMITEDHGY2024-12-16
09420060201666Gen. 2 Silicone Breast Pump & Flower Stopper Set - 150ml - LavenderTHINK GREEN LIMITEDHGY2024-12-16
09420060201673Gen. 2 Silicone Breast Pump & Flower Stopper Set - 150ml - BlushTHINK GREEN LIMITEDHGY2024-12-16
09420060201314Gen. 1 Silicone Breast Pump & Cap Set - BlushTHINK GREEN LIMITEDHGY2024-12-12
09420060201420Gen. 3 Multifunctional Silicone Breast Pump & Silicone Cap - 160ml - Grey Ring -THINK GREEN LIMITEDHGY2024-12-12
09420060201437Gen. 3 Multifunctional Silicone Breast Pump & Silicone Cap - 160ml - Peach Ring THINK GREEN LIMITEDHGY2024-12-12
09420060201444Gen. 3 Multifunctional Silicone Breast Pump & Silicone Cap - 250ml - Grey Ring -THINK GREEN LIMITEDHGY2024-12-12
09420060201468New Mum Starter Pack (Non-Vent Cap)THINK GREEN LIMITEDHGY2024-12-12