SPIKE, BLOOD W/ 1/4" CONNECTOR COVER

Basic Information

• Brand Name: SPIKE, BLOOD W/ 1/4" CONNECTOR COVER
• Primary DI: B0663011030000
• Version / Model: 301103-000
• Catalog Number: 301103-000
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-12
• Public Version: 3
• Public Version Date: 2023-06-20
• Public Version Status: Update
• Public Device Record Key: 7dd302d7-d908-4387-ab5e-95b47e5b2655

Device Description

A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device.

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: No
• 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: Yes
• 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
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	870.4290	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
Package	B0663011030007	HIBCC	PARTIAL CASE	75	In Commercial Distribution
Primary	B0663011030000	HIBCC
Package	B0663011030006	HIBCC	PARTIAL CASE	50	In Commercial Distribution
Package	B0663011030005	HIBCC	CASE	100	In Commercial Distribution
Package	B0663011030003	HIBCC	INNER CARTON	25	In Commercial Distribution

Customer Contacts

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