N/A

Basic Information

• Brand Name: N/A
• Primary DI: 24710810081754
• Version / Model: 5150
• Catalog Number: Silicone Rendell Baker Mask, Size 0
• Company Name: GALEMED CORPORATION
• Labeler DUNS: 656854379
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2015-10-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: feee2bc3-580d-4909-8254-4a1f85fb2124

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: 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: Yes
• 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
31254	Anaesthesia mask strap, reusable	A band of material designed to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and often affixed to a special stabilizing device (e.g., with hooks) located on the gas connection port of the mask. It is typically used for anaesthesia of long duration. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	44710810081758	GS1	Carton	12	In Commercial Distribution
Primary	24710810081754	GS1
Unit of Use	94710810081753	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Prevent from sunlight/Stay Dry