AccessGUDID - DEVICE: Lansinoh (00044677533515)

GUDID

Device Identifier (DI) Information

Brand Name: Lansinoh
Version or Model: Smartpump 3.0 Double Electric Breast Pump
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 53351
Company Name: LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI

Primary DI Number: 00044677533515
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 502960539 *Terms of Use

Device Description: The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby.

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):	No
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 [?]
K222726	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
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 41 and 95 Degrees Fahrenheit
Storage Environment Temperature: between 41 and 95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8888972f-2220-4c62-b311-c1f4a34431c4
Public Version Date: July 11, 2023
Public Version Number: 1
DI Record Publish Date: July 03, 2023