SWINGMED

Basic Information

• Brand Name: SWINGMED
• Primary DI: 06947656115181
• Version / Model: NC005
• Company Name: Guangzhou Berrcom Medical Device Co., Ltd
• Labeler DUNS: 529391821
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-09
• Public Version: 1
• Public Version Date: 2024-01-17
• Public Version Status: New
• Public Device Record Key: 370a509f-b181-4304-950f-ad8b2b0082b2

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	874.5550	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56552	HLA class II antibody identification panel IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the identification of one or multiple antibodies to HLA class II antigens in a clinical specimen, using solid phase antigens together with an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16947656115188	GS1	Cartoon	40	In Commercial Distribution
Primary	06947656115181	GS1