DORA

Basic Information

• Brand Name: DORA
• Primary DI: 06948082749698
• Version / Model: BAIN-A.V.F-007SE
• Company Name: Bain Medical Equipment (Guangzhou) Co., Ltd.
• Labeler DUNS: 526972767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-11
• Public Version: 1
• Public Version Date: 2023-04-19
• Public Version Status: New
• Public Device Record Key: f94df44b-a446-41b6-9dc3-610483de2287

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FIE	Needle, Fistula	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12741	Haemodialysis needle	A sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16948082749695	GS1		50	In Commercial Distribution
Primary	06948082749698	GS1
Package	26948082749692	GS1		10	In Commercial Distribution