AccessGUDID - DEVICE: NovaKit Exam Pack (NovaKit) (00850681007191)

GUDID

Device Identifier (DI) Information

Brand Name: NovaKit Exam Pack (NovaKit)
Version or Model: NA-DSP2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA-DSP2
Company Name: Novasignal Corp.

Primary DI Number: 00850681007191
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078766464 *Terms of Use

Device Description: The NovaKit contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
63568	Noninvasive vascular ultrasound support kit	A collection of non-sterile, non-powered, noninvasive devices intended to support a noninvasive vascular ultrasound system during location and assessment of vascular flow using ultrasound/Doppler/transit time technology. It consists of non-electronic supportive devices such as patient pads/positioners, transducer covers, and skin marking stickers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic
IYN	System, Imaging, Pulsed Doppler, Ultrasonic
OQQ	Diagnostic Ultrasonic Transducer, Robotic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180455	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: 3296fc09-e056-4af4-b34b-cf7ed6359aca
Public Version Date: September 08, 2020
Public Version Number: 1
DI Record Publish Date: August 31, 2020