Sunmed

Basic Information

• Brand Name: Sunmed
• Primary DI: 00847946046170
• Version / Model: 912-0011-20
• Company Name: Zoll Medical Corporation
• Labeler DUNS: 055363428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-22
• Public Version: 2
• Public Version Date: 2022-02-08
• Public Version Status: Update
• Public Device Record Key: 12406cc0-1a62-453d-bcf3-0704012a24e8

Device Description

MASK, FLEX CPAP, #6, X-LARGE ADULT, CASE OF 20

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
BSJ	MASK, GAS, ANESTHETIC	Anesthesiology	868.5550	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	00847946046170	GS1

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: Low: 0 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 0 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 0 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 0 – 0 Degrees Celsius