Disposable pouch(25/box)

Basic Information

• Brand Name: Disposable pouch(25/box)
• Primary DI: 06944904086484
• Version / Model: 115-032957-00
• Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Labeler DUNS: 654671304
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: 59c0d312-e787-426a-994b-a2d6f2a3bd07

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MSX	SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17115	Noninvasive device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06944904086484	GS1
Unit of Use	06944904090764	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150632	000