Infusion Set for Single Use

Basic Information

• Brand Name: Infusion Set for Single Use
• Primary DI: 06970440020026
• Version / Model: AD0102
• Company Name: Shinva Ande Healthcare Apparatus Co., Ltd
• Labeler DUNS: 421062164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-15
• Public Version: 5
• Public Version Date: 2022-10-10
• Public Version Status: Update
• Public Device Record Key: 8ccad693-52ee-4f0b-b886-e76da1a4b331

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36244	Electronic gravity infusion controller administration set	A collection of devices designed for the intravenous (IV) administration of fluid from a container, through an automated infusion controller, to a catheter/needle hub or extension tube set at the patient site. The collection typically consists of plastic tubing, a check valve, a roller clamp, a Y-piece connector for secondary tubing attachment, and Luer connectors at both ends. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	06970440020149	GS1		6	In Commercial Distribution
Primary	06970440020026	GS1
Package	06970440020132	GS1		50	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K162601	000