35X-NM ProFlexx®

Basic Information

• Brand Name: 35X-NM ProFlexx®
• Primary DI: 00190790000356
• Version / Model: 0015789
• Company Name: FERNO-WASHINGTON, INC.
• Labeler DUNS: 004239034
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-22
• Public Version: 3
• Public Version Date: 2022-08-31
• Public Version Status: Update
• Public Device Record Key: 8e19a079-ea82-446a-bfe5-22a58f06baab
• Distribution End Date: 2022-08-30

Device Description

35X-NM ProFlexx®, Non Magnetic

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
FPO	Stretcher, Wheeled	General Hospital	880.6910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35843	Ambulance stretcher, manual	A manually-operated device consisting of a platform mounted on a wheeled frame designed for use by emergency medical services (EMS) primarily to facilitate easy transport of a recumbent patient to and from ambulance vehicles (e.g., automobiles, aeroplanes, helicopters, boats); it does not include a powered or powered-assisted lifting mechanism. It is typically constructed of lightweight materials and has an undercarriage that opens and folds when it is removed from or pushed into the ambulance; it also usually includes locking devices that match with the locking/docking devices in the ambulance.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190790000356	GS1

Customer Contacts

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