Setmark Inc.

Basic Information

• Brand Name: Setmark Inc.
• Primary DI: 00854204008597
• Version / Model: NF300/627710
• Company Name: SETMARK INC.
• Labeler DUNS: 080798558
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-23
• Public Version: 1
• Public Version Date: 2020-03-31
• Public Version Status: New
• Public Device Record Key: bb3959e0-4135-48c2-b009-0c5861fa31d0

Device Description

Cut - off Hydraulic stretcher, includes O2 tank & IV pole - Non Ferrous.NF-300

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: 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
FPO	Stretcher, Wheeled	General Hospital	880.6910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35892	Hospital stretcher, manual	A manually-operated device consisting of a platform mounted on a wheeled frame designed primarily to facilitate easy transport of a recumbent patient within a healthcare facility; it may include side rails, supports for fluid infusion equipment, and patient securement straps. The device may also be used as a treatment table (e.g., in an emergency, recovery, or labour room), or as a bed in some intensive and specialized care units or under high patient census conditions (e.g., disasters).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854204008597	GS1