Level 1

Basic Information

• Brand Name: Level 1
• Primary DI: 20695085400100
• Version / Model: PF-1
• Company Name: SMITHS MEDICAL MD, INC.
• Labeler DUNS: 106712748
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-25
• Public Version: 1
• Public Version Date: 2019-10-03
• Public Version Status: New
• Public Device Record Key: 1e0826a4-2c6a-4843-9230-df7e99c98220

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Sterilization Methods: Ethylene Oxide

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	30695085400107	GS1	Pallet	4	In Commercial Distribution
Package	10695085400103	GS1	Case	60	In Commercial Distribution
Primary	20695085400100	GS1

Premarket Submissions

Submission Number	Supplement Number
BK860023	000