Level 1

Basic Information

• Brand Name: Level 1
• Primary DI: 40695085400302
• Version / Model: SC-3
• 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: 5eab7d5a-9218-4346-a8a8-9457f2957898

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
KZL	DEVICE, WARMING. BLOOD AND PLASMA	Hematology	864.9205	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32172	Intravenous line stopcock	A sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30695085400305	GS1	CASE	160	In Commercial Distribution
Package	20695085400308	GS1	CASE	40	In Commercial Distribution
Package	10695085400301	GS1	CASE	20	In Commercial Distribution
Primary	40695085400302	GS1

Premarket Submissions

Submission Number	Supplement Number
BK860023	000