Level 1

Basic Information

• Brand Name: Level 1
• Primary DI: 40695085410806
• Version / Model: PC-8
• Company Name: SMITHS MEDICAL MD, INC.
• Labeler DUNS: 106712748
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 4
• Public Version Date: 2018-08-17
• Public Version Status: Update
• Public Device Record Key: 767482ea-bfc8-42f6-b203-ec71109884e2

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: 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
LGZ	Warmer, thermal, infusion fluid	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18067	Intravenous line recessed-needle connector	A sterile device designed to allow access to either the Y-site of an intravenous (IV) line or an injection adaptor on the infusion catheter. Typically, a needle located inside a plastic housing can be inserted into a standard septum and a Luer fitting located at the opposite end allows the connection of a syringe or infusion set. A manual or automated mechanism moves the housing to protect the operator from the needle once the infusion is finished. The device is intended to eliminate an exposed needle after administration of medications. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10695085410805	GS1	CASE	20	In Commercial Distribution
Primary	40695085410806	GS1
Package	20695085410802	GS1	CASE	40	In Commercial Distribution
Package	30695085410809	GS1	CASE	160	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K911383	000