Model: J
Catalog: PID6F23021PW
DI: 10884450439217
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3b658e62-1797-462b-9266-af61c98a376d
Distribution Status:
In Commercial Distribution
DUNS Number:
184763290
Device Count:
5
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
20884450439214
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
4
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10884450439217
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10884450439217
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00884450439210
Item #3 - Device ID Type:
Unit of Use
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
Device Sizes
Item #1 - Size Text:
Guide Wire Diameter-0.021" (0.53 mm)
Item #1 - Size Type:
Device Size Text, specify
Item #2 - Size Text:
Sheath Length (cm)-23 cm (9")
Item #2 - Size Type:
Device Size Text, specify
Item #3 - Size Text:
Needle Gauge (G)-22G
Item #3 - Size Type:
Device Size Text, specify
Item #4 - Size Text:
Sheath French Size (F)-6F
Item #4 - Size Type:
Device Size Text, specify