AccessGUDID - DEVICE: DOPPLEX (05051968017666)

GUDID

Device Identifier (DI) Information

Brand Name: DOPPLEX
Version or Model: DFK2-USA-D900-P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DFK2-USA-D900-P
Company Name: HUNTLEIGH HEALTHCARE LIMITED

Primary DI Number: 05051968017666
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 217207083 *Terms of Use

Device Description: DIABETIC FOOT KIT-USA MINI DOPPLX

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?
44311	Noninvasive vascular ultrasound system	An electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNG	Monitor, Ultrasonic, Fetal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K930200	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
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: less than 93 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 860 and 1060 millibar
Storage Environment Atmospheric Pressure: between 860 and 1060 millibar

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b61437ec-2e34-419a-8f63-c085858282b0
Public Version Date: November 03, 2023
Public Version Number: 4
DI Record Publish Date: August 25, 2016