Sunmed High Pressure Line

Basic Information

• Brand Name: Sunmed High Pressure Line
• Primary DI: 06947358520405
• Version / Model: 400psi, 15cm
• Company Name: Sunny Medical Device (Shenzhen) Co., Ltd.
• Labeler DUNS: 529639795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-15
• Public Version: 2
• Public Version Date: 2021-06-01
• Public Version Status: Update
• Public Device Record Key: 5de1bf72-e31b-4ccf-9a99-6e18e6a6e4f0

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61836	Cardiopulmonary bypass system pressure-monitoring tubing	A sterile length of flexible tube intended to interface a pressure monitor/manometer with a cardiopulmonary bypass system to allow fluid pressure to be measured; connectors are typically included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06947358520405	GS1

Premarket Submissions

Submission Number	Supplement Number
K140356	000