HUDSON RCI

Basic Information

• Brand Name: HUDSON RCI
• Primary DI: 14026704629975
• Version / Model: IPN049606
• Catalog Number: 15800
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-08
• Public Version: 2
• Public Version Date: 2020-03-04
• Public Version Status: Update
• Public Device Record Key: f53bed0c-2e37-484d-8408-47433f25c865

Device Description

HUDSON RCI CLEAR COMFORT AIR CUSHION FACE MASK NEONATE

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
BSJ	MASK, GAS, ANESTHETIC	Anesthesiology	868.5550	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46232	Anaesthesia face mask, single-use	A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	34026704629979	GS1	Case	30	In Commercial Distribution
Primary	14026704629975	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	45	Millimeter
Width	60	Millimeter
Length	65	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -5 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -5 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity