Gongdong

Basic Information

• Brand Name: Gongdong
• Primary DI: 06947462405322
• Version / Model: GD5334T1
• Company Name: ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
• Labeler DUNS: 529309049
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2023-11-09
• Public Version: 1
• Public Version Date: 2023-11-17
• Public Version Status: New
• Public Device Record Key: 7eadf04e-b7d5-4812-a06d-71d2ad3220b3

Device Description

Double Rattle Snap Safety Snap Diaper Cup "90ml with 53mm Lid, EO Sterilized

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMH	Container, Specimen, Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57919	24-hour urine specimen container IVD, no additive	A capped plastic receptacle, typically 2 to 4 litres, with no additives and intended to be used for the collection, and preservation and/or transport, of urine collected over a 24-hour period for analysis and/or other investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	86947462405328	GS1
Primary	06947462405322	GS1