Ameda, Inc. 10011

GUDID 10810725023126

22.5mm Reducing Insert

AMEDA, INC.

Breast pump support kit, single-use, sterile

• Primary Device ID: 10810725023126
• NIH Device Record Key: f72e2554-ad05-45fa-8109-7b923ba088db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ameda, Inc.
• Version Model Number: 10011
• Catalog Number: 10011
• Company DUNS: 078719435
• Company Name: AMEDA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (866) 992-6332
• Email: parentcare@ameda.com
• Phone: (866) 992-6332
• Email: parentcare@ameda.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810725023129 [Primary]
GS1	10810725023126 [Package]; Contains: 00810725023129; Package: Outer Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011519

FDA Product Code

• HGX: Pump, Breast, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Ameda, Inc.]

• 10810725023171: Locking Ring and Disc
• 10810725023164: 30.5mm Breast Flange
• 10810725023157: 28.5mm Breast Flange
• 10810725023140: 25mm Breast Flange
• 10810725023126: 22.5mm Reducing Insert
• 10810725023119: 21mm Flexishield
• 10810725023096: Adapter Cap
• 10810725023041: Breast Flanges 28.5mm Bulk Sterile
• 10810725023034: Dual Kit w/ Flanges & One-Hand Adapter
• 10810725023027: Silicone Tubing
• 10810725023010: Clear Check Valve
• 00810725022894: Detachable Power Cord, Elite, Nth America
• 00810725021590: Ameda Platinum Pump Refurbished
• 10810725022853: Silicone Diaphragm
• 00810725021569: Elite Breast Pump Refurb
• 10810725022723: Ameda Manual Pump
• 00810725022603: Cord, Platinum, NA
• 10810725022488: One-Hand Manual Pump Adapter
• 10810725022464: Spare Parts Kit
• 10810725022396: Dual HygieniKit wAdap ST
• 10810725022358: OHBP w/ STD Flange
• 10810725022273: ComfortGel HydroGel Pads (Bulk)
• 00810725021545: Elite Breast Pump w/ 9ft Cord
• 00810725021552: Elite Breast Pump
• 00810725021477: Purely Yours Pump w/ Carry All
• 10810725021665: Store 'N Pour Milk Storage Bages (50 count + 2 adapters)
• 10810725021627: Dual HygieniKit (STL)
• 00810725021484: Purely Yours Ultra Dottie
• 10810725020750: Store 'N Pour Bulk
• 10810725020743: One-Hand Pump Custom
• 00810725020739: One-Hand Pump w/ Flange Inserts
• 10810725020729: Dual HygieniKit
• 10810725020705: Dual HygieniKit
• 10810725020699: HygieniKit w/ Flange Inserts (STL)
• 10810725020682: Dual HygieniKit w/ Adapter (Non-Sterile)
• 10810725020675: Hospital Discharge Kit Manual Pump
• 10810725020651: Breast Pumping Starter Kit
• 10810725020644: One-Hand Manual Pump w/ Flexishield
• 10810725020613: Dual HygieniKit (STL)
• 10810725020606: Dual HygieniKit w/ Adapter & Flexishield (STL)
• 10810725020590: Dual HygeiniKit w/ Manual Adapter (STL)
• 10810725020583: Single HygieniKit (STL)
• 10810725020576: Single HygieniKit w/ Manual Adapter (STL)
• 10810725020552: One-Hand Manual Pump Adapter
• 10810725020545: One-Hand Pump HygieniKit Adapter (STL)
• 10810725020521: Single Short Term HygieniKit STL
• 00810725023402: Ameda Platinum Pump RoHS
• 10810725020378: One-Hand Manual Pump w/ Tote
• 20810725020160: ComfortGel HydroGel Pads (STL)
• 00810725020128: Flexishield Areola Stimulators - 2