FDA.reportPublic FDA data

Ameda, Inc.

Primary DI
10810725020552
Brand
Ameda, Inc.
Company
AMEDA, INC.
Model
17145
Catalog number
17145
Device description
One-Hand Manual Pump Adapter
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
10810725020552PackageGS1100In Commercial Distribution
00810725020555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081072502055210810725020552
00810725020555008107250205558107250205550810725020555

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
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
078719435
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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