AccessGUDID - DEVICE: VASCULAR SONO (04048223056172)

GUDID

Device Identifier (DI) Information

Brand Name: VASCULAR SONO
Version or Model: 1187-4F070
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1187-4F070
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223056172
Issuing Agency: GS1
Commercial Distribution End Date: May 25, 2024
Device Count: 25
Labeler D-U-N-S® Number*: 317654283 *Terms of Use
Previous DI: 14048223021603

Device Description: 1187-4F070

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):	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?
58865	Vascular catheter introduction set, nonimplantable	A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	INTRODUCER, CATHETER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 10 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e0a9aceb-b214-4866-b91e-9b1df6b6e7a1
Public Version Date: May 27, 2024
Public Version Number: 4
DI Record Publish Date: April 02, 2021