Level 1

Basic Information

• Brand Name: Level 1
• Primary DI: 20695085406010
• Version / Model: DI-60HL
• 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: 7
• Public Version Date: 2021-03-24
• Public Version Status: Update
• Public Device Record Key: 225c1bd8-c811-46c6-a151-a4fa4f087b78

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: Yes
• 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
41609	Heat-exchanging intravenous administration set	A collection of noninvasive devices designed to directly warm and conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It does not include devices intended to be used invasively. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20695085406010	GS1
Package	10695085406013	GS1	Carton	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
BK860023	000