Device
PSP,US,DIGNITY HEALTH-CHANDL
Manufacturer
MEDLINE INDUSTRIES, INC.
Model: VASC1933 Catalog: VASC1933 DI: 10198459669545 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-08 Current Version: 2026-05-18
Description
PSP,US,DIGNITY HEALTH-CHANDL
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: f5442082-5a9a-4d94-bf5f-db10d4c12c4f
Distribution Status: In Commercial Distribution
DUNS Number: 025460908
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
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 - Pkg Type: CS
Item #1 - Device ID: 40198459669546
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 15
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 10198459669545
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 10198459669545
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 16545
Name: Angiography kit
Definition:
A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.
FDA Product Codes
OES
Cardiac catheterization kit