AccessGUDID - DEVICE: Spectra (08809108017710)

GUDID

Device Identifier (DI) Information

Brand Name: Spectra
Version or Model: Spectra Wearable
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MM011500
Company Name: UZINMEDICARE CO.,LTD

Primary DI Number: 08809108017710
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688451947 *Terms of Use

Device Description: The Spectra Wearable is powered breast pumps intended for use of lactating women to stimulate, express and collect milk from user’s breast. The final product is packed in a box with neccessary parts including breast shied, silicone valve, silicone membrane, bottle, bottle connector, connector pin, airtight cap, pp bottle, nipple, screw cap, cover, power adapter and instruction for use.

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:	Yes
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 [?]
K220926	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
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f368f1f-73ea-4bd7-b7a7-d73ab551a73e
Public Version Date: April 23, 2025
Public Version Number: 1
DI Record Publish Date: April 15, 2025