Level 1

Basic Information

• Brand Name: Level 1
• Primary DI: 30695085433006
• Version / Model: F-30
• 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: 8b0e3136-4ca6-46a1-8ac2-26a678c31015

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
35072	Intravenous line filter	A sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10695085433002	GS1	BOX	20	In Commercial Distribution
Primary	30695085433006	GS1
Package	20695085433009	GS1	BOX	80	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
BK860023	000