BLUE CAP, NON-VENTED FEMALE

Basic Information

• Brand Name: BLUE CAP, NON-VENTED FEMALE
• Primary DI: B066000325011NS1
• Version / Model: 000325-011NS
• Catalog Number: 000325-011NS
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5000
• Record Status: Published
• Publish Date: 2015-10-13
• Public Version: 4
• Public Version Date: 2023-07-13
• Public Version Status: Update
• Public Device Record Key: d9b26a8f-67a2-41c0-a61a-3c28c1536b32

Device Description

A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

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
63614	Luer-formatted protective cap	A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B066000325011NS6	HIBCC	CASE	30000	In Commercial Distribution
Primary	B066000325011NS1	HIBCC
Package	B066000325011NS5	HIBCC	PARTIAL CASE	25000	In Commercial Distribution
Package	B066000325011NS4	HIBCC	PARTIAL CASE	20000	In Commercial Distribution
Package	B066000325011NS3	HIBCC	PARTIAL CASE	15000	In Commercial Distribution
Package	B066000325011NS2	HIBCC	PARTIAL CASE	10000	In Commercial Distribution
Unit of Use	B066000325011NS0	HIBCC

Customer Contacts

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