HUDSON RCI

Basic Information

• Brand Name: HUDSON RCI
• Primary DI: 04026704580538
• Version / Model: IPN042639
• Catalog Number: 15911
• 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: 2019-12-11
• Public Version Status: Update
• Public Device Record Key: bc1e7074-0d9d-43d4-91d8-9d4c19294b25

Device Description

MASK HARNESS,PEDIATRIC,REUSABLE

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: 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
Direct Marking	34026704580539	GS1
Package	24026704580532	GS1	Case	10	Not in Commercial Distribution	2019-09-30
Primary	04026704580538	GS1

Customer Contacts

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