AccessGUDID - DEVICE: moorFLPI-2 Clinical PC Software (15060484490157)

GUDID

Device Identifier (DI) Information

Brand Name: moorFLPI-2 Clinical PC Software
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MOOR INSTRUMENTS LIMITED

Primary DI Number: 15060484490157
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 398037580 *Terms of Use

Device Description: moorFLPI-2 Clinical PC Software V1

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58447	Cutaneous microcirculation laser Doppler imaging device	A mobile, mains electricity (AC-powered) device designed to use the laser Doppler imaging (LDI) technique of skin blood flow to visualize the perfusion of cutaneous microcirculation over a surface area. It typically consists of a dedicated camera system which includes a laser, an imaging sensor and electronics, mounted on a wheeled pedestal. The device works by non-invasively detecting the frequency change of the laser radiation reflected by the moving red blood cells in the small vessels. It is used in pre-, intra- [in the operating room (OR)], and postoperative clinical assessment, typically to evaluate burn wound healing potential, or for assessing reperfusion of cutaneous flaps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DPT	Probe, Blood-Flow, Extravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122943	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 47fad94a-8e96-4962-aff4-d5d73e7b05d4
Public Version Date: July 04, 2022
Public Version Number: 2
DI Record Publish Date: December 13, 2018