CIV

Basic Information

• Brand Name: CIV
• Primary DI: 00817708020106
• Version / Model: CIV-035
• Catalog Number: CIV-035
• Company Name: EMED TECHNOLOGIES CORPORATION
• Labeler DUNS: 622637544
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 7
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: b42e563d-c8ee-4e63-a74f-0542864aa70b
• Distribution End Date: 2020-09-24

Device Description

Fluid Delivery Set

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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPK	Tubing, Fluid Delivery	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58977	Basic intravenous administration set, noninvasive	A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817708020106	GS1
Unit of Use	00817708020090	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K935642	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -5 – 40 Degrees Celsius