Lifeguard

Basic Information

• Brand Name: Lifeguard
• Primary DI: H787LG22100NY5
• Version / Model: LG-22-100NY
• Company Name: ANGIODYNAMICS, INC.
• Labeler DUNS: 601994184
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 5
• Public Version Date: 2021-10-28
• Public Version Status: Update
• Public Device Record Key: a0b30c50-1083-4a32-86d6-250fcfde44a7
• Distribution End Date: 2021-10-07

Device Description

LIFEGUARD Safety Needle

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: MR Conditional
• 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
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17701	Vascular port administration set	A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	H787LG22100NY5	HIBCC
Unit of Use	H787LG22100NY0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K013871	000

Device Sizes

Type	Value	Unit	Text
Length	1	Inch
Needle Gauge	22	Gauge