AccessGUDID - DEVICE: Easy Freeze (00814079020216)

GUDID

Device Identifier (DI) Information

Brand Name: Easy Freeze
Version or Model: 63.00.207
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 63.00.207
Company Name: Ardo medical AG

Primary DI Number: 00814079020216
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 481670396 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45136	Breast milk bag	A sterile flexible sac designed for the collection and storage of breast milk. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGX	Pump, Breast, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141742	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e9eb1112-2906-4699-b1e2-01904cc5b117
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 30, 2016