Parker

Basic Information

• Brand Name: Parker
• Primary DI: 00607411959424
• Version / Model: H-PFOL-45
• Catalog Number: H-PFOL-45
• Company Name: SALTER LABS
• Labeler DUNS: 022721133
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-03
• Public Version: 2
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: a16a9589-45d7-4b05-af52-9a3742101429

Device Description

Endotracheal Tube, Preformed, Oral, Low Profile Cuffed (PFOL), Parker, 4.5mm Parker Original DID: 1074906505130452.

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	868.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46967	Basic endotracheal tube, single-use	A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20607411959428	GS1		100	In Commercial Distribution
Primary	00607411959424	GS1
Package	10607411959421	GS1		10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K984528	000