HUDSON RCI

Basic Information

• Brand Name: HUDSON RCI
• Primary DI: 04026704580545
• Version / Model: IPN042640
• Catalog Number: 15920
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-15
• Public Version: 2
• Public Version Date: 2019-12-12
• Public Version Status: Update
• Public Device Record Key: 3ee941e0-72e9-46f5-a88e-29bd2516299b

Device Description

Universal 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: 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
BTK	STRAP, HEAD, GAS MASK	Anesthesiology	868.5560	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
Package	24026704580549	GS1	Case	50	Not in Commercial Distribution	2019-09-30
Primary	04026704580545	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]