Ameda, Inc. 17245

GUDID 10810725020750

Store 'N Pour Bulk

AMEDA, INC.

Breast milk bag
Primary Device ID10810725020750
NIH Device Record Keyd177d650-20c5-4cb3-9f47-e00c0eb15c19
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmeda, Inc.
Version Model Number17245
Catalog Number17245
Company DUNS078719435
Company NameAMEDA, INC.
Device Count150
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone(866) 992-6332
Emailparentcare@ameda.com
Phone(866) 992-6332
Emailparentcare@ameda.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween -10 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810725020753 [Primary]
GS100810725021613 [Unit of Use]
GS110810725020750 [Package]
Contains: 00810725020753
Package: Outer Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGXPump, Breast, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Ameda, Inc.]

10810725023171Locking Ring and Disc
1081072502316430.5mm Breast Flange
1081072502315728.5mm Breast Flange
1081072502314025mm Breast Flange
1081072502312622.5mm Reducing Insert
1081072502311921mm Flexishield
10810725023096Adapter Cap
10810725023041Breast Flanges 28.5mm Bulk Sterile
10810725023034Dual Kit w/ Flanges & One-Hand Adapter
10810725023027Silicone Tubing
10810725023010Clear Check Valve
00810725022894Detachable Power Cord, Elite, Nth America
00810725021590Ameda Platinum Pump Refurbished
10810725022853Silicone Diaphragm
00810725021569Elite Breast Pump Refurb
10810725022723Ameda Manual Pump
00810725022603Cord, Platinum, NA
10810725022488One-Hand Manual Pump Adapter
10810725022464Spare Parts Kit
10810725022396Dual HygieniKit wAdap ST
10810725022358OHBP w/ STD Flange
10810725022273ComfortGel HydroGel Pads (Bulk)
00810725021545Elite Breast Pump w/ 9ft Cord
00810725021552Elite Breast Pump
00810725021477Purely Yours Pump w/ Carry All
10810725021665Store 'N Pour Milk Storage Bages (50 count + 2 adapters)
10810725021627Dual HygieniKit (STL)
00810725021484Purely Yours Ultra Dottie
10810725020750Store 'N Pour Bulk
10810725020743One-Hand Pump Custom
00810725020739One-Hand Pump w/ Flange Inserts
10810725020729Dual HygieniKit
10810725020705Dual HygieniKit
10810725020699HygieniKit w/ Flange Inserts (STL)
10810725020682Dual HygieniKit w/ Adapter (Non-Sterile)
10810725020675Hospital Discharge Kit Manual Pump
10810725020651Breast Pumping Starter Kit
10810725020644One-Hand Manual Pump w/ Flexishield
10810725020613Dual HygieniKit (STL)
10810725020606Dual HygieniKit w/ Adapter & Flexishield (STL)
10810725020590Dual HygeiniKit w/ Manual Adapter (STL)
10810725020583Single HygieniKit (STL)
10810725020576Single HygieniKit w/ Manual Adapter (STL)
10810725020552One-Hand Manual Pump Adapter
10810725020545One-Hand Pump HygieniKit Adapter (STL)
10810725020521Single Short Term HygieniKit STL
00810725023402Ameda Platinum Pump RoHS
10810725020378One-Hand Manual Pump w/ Tote
20810725020160ComfortGel HydroGel Pads (STL)
00810725020128Flexishield Areola Stimulators - 2

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