Level 1

Basic Information

• Brand Name: Level 1
• Primary DI: 50695085829261
• Version / Model: H-31-EN
• 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: 2fc281f7-06a1-456f-9f72-1ea83d88f25d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSB	Warmer, blood, non-electromagnetic radiation	Hematology	864.9205	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47040	Blood/fluid warmer air/foam detector	A mains electricity (AC-powered) device that is typically a module or a component of a high-flow blood/fluid warmer, and that provides an alarm and/or stops the flow of fluid when it detects air or foam in the de-aeration chamber of the blood/fluid warming set and/or when the fluid level in the de-aeration chamber is too low.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	50695085829261	GS1

Premarket Submissions

Submission Number	Supplement Number
BK020043	000