AccessGUDID - DEVICE: Gongdong (06947462403687)

GUDID

Device Identifier (DI) Information

Brand Name: Gongdong
Version or Model: G2001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.

Primary DI Number: 06947462403687
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5000
Labeler D-U-N-S® Number*: 529309049 *Terms of Use

Device Description: Quantisal Expressor (empty filter frit) with lid and ring

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):	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?
62669	Clinical specimen extraction buffer IVD	A buffered solution intended to be used for the processing and preparation of a clinical specimen, for subsequent in vitro diagnostic testing, by extraction of specific target analytes present in the clinical specimen (e.g., proteins, antigens).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: Yes
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: a53dcdeb-0244-49e7-967e-ea1a39b7d7ee
Public Version Date: September 15, 2023
Public Version Number: 1
DI Record Publish Date: September 07, 2023