PF 6055 SPP Kit

Basic Information

• Brand Name: PF 6055 SPP Kit
• Primary DI: 07332834001155
• Version / Model: PF 6055
• Catalog Number: 93-00232
• Company Name: Perimed AB
• Labeler DUNS: 354765570
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-31
• Public Version: 1
• Public Version Date: 2023-02-08
• Public Version Status: New
• Public Device Record Key: dda4e51d-705b-4861-bb5e-5132e6212a13

Device Description

PF 6055 SPP Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
60451	Laser Doppler blood flowmeter	A mobile, mains electricity (AC-powered) device designed to use laser Doppler techniques to measure the velocity of micro- and macrovascular blood circulation to assess of the extent of vascular flow restrictions [e.g., clots, stenosis, mechanical damage, and peripheral vascular disease (PVD)]. It typically measures blood flow/perfusion, transcutaneous oxygen (TCOM) and/or carbon dioxide, and may have modules for heat provocation and pressure control. It typically consists of various laser Doppler probes, temperature measurement sensors, and pressure measuring cuff/sensors connected to a software-controlled control/visual display unit.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07332834001155	GS1

Premarket Submissions

Submission Number	Supplement Number
K152930	000