Model: IPN930593
Catalog: IDLX-45552-HPK
DI: 10801902222043
Status: New
MRI: MR Safe
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ec934e7e-3057-462e-a7af-55ce46ba88be
Distribution Status:
In Commercial Distribution
DUNS Number:
002348191
Device Count:
1
DM Exempt:
Yes
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 - Pkg Type:
CS
Item #1 - Device ID:
20801902222040
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
3
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10801902222043
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10801902222043
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 36257
Name: Peripherally-inserted central venous catheter
Definition:
A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.
FDA Product Codes
LJS
Catheter, intravascular, therapeutic, long-term greater than 30 days
Premarket Submissions
Submission Number:
K112896
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Avoid excessive heat about 30 deg C (86 deg F).