AccessGUDID - DEVICE: SonoTT Vascular Probe (04062114000136)

GUDID

Device Identifier (DI) Information

Brand Name: SonoTT Vascular Probe
Version or Model: 11345
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11345
Company Name: em-tec GmbH

Primary DI Number: 04062114000136
Issuing Agency: GS1
Commercial Distribution End Date: September 20, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 320025190 *Terms of Use

Device Description: SonoTT Vascular Probe: The SonoTT Vascular Probes for measuring flow in blood vessels are available in different sizes for vessel diameters of 1.5 to 10 mm (more sizes on request). The probes can be sterilised up to 50 times using all established sterilisation methods (steam, EO, LTP, Formaldehyde). Automatic washing machines can be used to clean the probes.

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):	No
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?
61422	Noninvasive vascular ultrasound system, line-powered	A mains electricity (AC-powered) device assembly consisting of a desktop unit, a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis), ankle pressure index, and/or blood flow wave form recording.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DPW	Flowmeter, Blood, Cardiovascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111730	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide

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: 54cbe8b4-b5eb-47db-a475-3be9813ddd8c
Public Version Date: October 22, 2018
Public Version Number: 1
DI Record Publish Date: September 20, 2018