Model: C
Catalog: PID7F11025PW
DI: 00884450684665
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
41fcc5c0-f9ae-4f28-af45-4da5705c8a2f
Distribution Status:
In Commercial Distribution
DUNS Number:
184763290
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00884450684665
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10884450684662
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
5
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00884450684665
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
20884450684669
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
4
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
10884450684662
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 58865
Name: Vascular catheter introduction set, nonimplantable
Definition:
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.
FDA Product Codes
DYB
Introducer, Catheter