Model: CENT-PL-350
Catalog: CENT-PL-350
DI: 09345390003523
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Distribution End: 9999-12-31
Description
ASSY,TUBE SET,CENTARGO SUDS 350,US (91850367)
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d87f5814-86e1-4d83-9875-5ce6f0b06af0
Distribution Status:
In Commercial Distribution
DUNS Number:
740733993
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
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:
Box
Item #1 - Device ID:
49345390003521
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
50
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
09345390003523
Item #1 - Pkg Discontinue Date:
9999-12-31
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
09345390003523
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 44685
Name: Radiographic procedure tubing
Definition:
A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).
FDA Product Codes
DXT
Injector And Syringe, Angiographic
IZQ
Injector, Contrast Medium, Automatic
Premarket Submissions
Submission Number:
K252689
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
-20
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
60
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
10
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
90
Item #2 - Storage Handling Type:
Storage Environment Humidity