Ameda, Inc.

Basic Information

• Brand Name: Ameda, Inc.
• Primary DI: 00810725020524
• Version / Model: 17105
• Catalog Number: 17105
• Company Name: AMEDA, INC.
• Labeler DUNS: 078719435
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: a9a7a3fb-0636-4429-9f1d-1fdeb4d78aee

Device Description

Single Short Term HygieniKit STL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	884.5160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12463	Breast pump support kit, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810725020521	GS1	Outer Carton	24	In Commercial Distribution
Primary	00810725020524	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K011519	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 130 Degrees Fahrenheit