AccessGUDID - DEVICE: BD Introsyte-N, BD Instaflash (50382903840217)

GUDID

Device Identifier (DI) Information

Brand Name: BD Introsyte-N, BD Instaflash
Version or Model: 384021
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 384021
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 50382903840217
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 124987988 *Terms of Use

Device Description: INTRODUCER INTROSYTE-N 1.9F 1.9CM

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":	Yes
For Single-Use:	Yes
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?
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 19 Millimeter
Device Size Text, specify: Size = Catheter Gauge = 26 Gauge (G)

Device Record Status

Public Device Record Key: 18648e85-9080-4c28-8edc-774ce4a29028
Public Version Date: August 07, 2025
Public Version Number: 7
DI Record Publish Date: October 20, 2016