Easy Freeze 63.00.207

GUDID 00814079020216

Easy Freeze breast milk bags for safe and space-saving storage of breast milk in your fridge or freezer.

Ardo medical AG

Breast milk bag
Primary Device ID00814079020216
NIH Device Record Keye9eb1112-2906-4699-b1e2-01904cc5b117
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy Freeze
Version Model Number63.00.207
Catalog Number63.00.207
Company DUNS481670396
Company NameArdo medical AG
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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+18444112736
Emailcustomer-service@ardo-usa.com
Phone+18444112736
Emailcustomer-service@ardo-usa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100814079020216 [Primary]
GS100814079020223 [Package]
Package: Box [18 Units]
In Commercial Distribution
GS100814079020230 [Unit of Use]

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 Date2016-09-30

Devices Manufactured by Ardo medical AG

07640108054470 - Alyssa Hands-Free2024-01-30 Breast Pump, electric, with hands-free-pumpset
07640108054494 - Hands-Free Double Pumpset2024-01-30 The Ardo Hands-Free Double Pumpset should be used in combination with the Ardo breastpumps and is intended for the expression an
00814079022210 - Double Clinic Pumpset2023-09-14 The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express an
07640108051516 - Bellis2023-06-01 Breast Pumps, electric, with cooling bag
07640108053961 - Alyssa to-go2023-06-01 Breast Pump, electric, with carry bag
07640109059627 - Tulips Size S2023-05-31 Nipple Shields Size S
00814079022111 - Tulips Size S2023-05-31 Nipple Shields Size S
07640108053640 - Alyssa Double Plus2022-08-25 Breast Pump Double, electric

Trademark Results [Easy Freeze]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EASY FREEZE
EASY FREEZE
85466893 4289960 Live/Registered
The Kong Company
2011-11-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.