AccessGUDID - DEVICE: Spectra (08809108012302)

GUDID

Device Identifier (DI) Information

Brand Name: Spectra
Version or Model: Spectra accessory (24mm shield set)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MM012302
Company Name: UZINMEDICARE CO.,LTD

Primary DI Number: 08809108012302
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(excluded bottle 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: 5d4fccb3-675f-48eb-b54d-f0b8bfa77e70
Public Version Date: September 20, 2024
Public Version Number: 5
DI Record Publish Date: November 25, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
28809108012306	50	08809108012302	In Commercial Distribution	Carton Box
28809108012412	48	08809108012302	In Commercial Distribution	Carton Box
18809108013108	3	08809108012302	In Commercial Distribution	Design box
28809108013105	18	18809108013108	In Commercial Distribution	Carton box