AccessGUDID - DEVICE: Duo Double Electric Breast Pump (00887529000465)

GUDID

Device Identifier (DI) Information

Brand Name: Duo Double Electric Breast Pump
Version or Model: AAA0021
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bistos Co., Ltd.

Primary DI Number: 00887529000465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 689908411 *Terms of Use

Device Description: The Duo Double Electric Breast Pump is a single user, double electric breast pump that includes customizable massage and expression modes and is capable of single and double pumping.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
38478	Breast pump, electric	A mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGX	Pump, Breast, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160274	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: 01769e84-842e-4be0-a4d8-2efec9246419
Public Version Date: November 05, 2021
Public Version Number: 1
DI Record Publish Date: October 28, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00887529000472	1	00887529000465	In Commercial Distribution	Gift Box
10887529000479	6	00887529000472	In Commercial Distribution	Carton Box
00887529000489	1	00887529000465	In Commercial Distribution	Gift Box(with Bag)
10887529000486	4	00887529000489	In Commercial Distribution	Carton Box(with Bag)