AccessGUDID - DEVICE: Spectra (08809108016553)

GUDID

Device Identifier (DI) Information

Brand Name: Spectra
Version or Model: Spectra accessory (24mm shield set)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MM012340-24mm
Company Name: UZINMEDICARE CO.,LTD

Primary DI Number: 08809108016553
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688451947 *Terms of Use

Device Description: Spectra accessory set for breast pump including 24mm breast shield set. Breast shield is a funnel shaped accessory, which come in contact with breast to express milk. It is connected to backdraft prevention unit (cap), pressure adjustment unit (silicon head) and bottle when used.

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?
61734	Breast pump support kit, reusable	A collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGX	Pump, Breast, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Lumen/Inner Diameter: 24 Millimeter

Device Record Status

Public Device Record Key: 0b92a803-7199-4c5f-ba01-355c516712e0
Public Version Date: September 13, 2024
Public Version Number: 3
DI Record Publish Date: January 15, 2024