HUDSON RCI

Basic Information

• Brand Name: HUDSON RCI
• Primary DI: 04026704387908
• Version / Model: IPN044945
• Catalog Number: 5385
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-16
• Public Version: 6
• Public Version Date: 2018-08-28
• Public Version Status: Update
• Public Device Record Key: afa50a13-8725-4f62-b24c-d46b35a68b34

Device Description

PEEP VALVE,DISPOSABLE

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: No
• 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
BTM	Ventilator, emergency, manual (resuscitator)	Anesthesiology	868.5915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46823	PEEP valve, single-use	A non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24026704387902	GS1	Box	10	Not in Commercial Distribution	2018-08-27
Primary	04026704387908	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K964719	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			PEEP Valve
Length	1.18	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in clean dry conditions away from heat and light.
• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius