SunMed

Basic Information

• Brand Name: SunMed
• Primary DI: 20889483228804
• Version / Model: 4-1054-23-10
• Company Name: SUNMED, LLC
• Labeler DUNS: 069009268
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-24
• Public Version: 2
• Public Version Date: 2023-10-11
• Public Version Status: Update
• Public Device Record Key: 021db08b-b95b-4c90-8c9f-6e1e61dfad84
• Distribution End Date: 2024-12-31

Device Description

Adult Mask Harness

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	868.5975	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60882	Anaesthesia mask strap, single-use	A non-sterile, non-latex strap/head harness intended to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and affixed to the mask. It is typically used for anaesthesia of long duration. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20889483228804	GS1