Model: IPNB00593
Catalog: ASK-15703-BFL
DI: 10801902226096
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
851d1773-ad2d-4fb2-904e-ba35f039ad9a
Distribution Status:
In Commercial Distribution
DUNS Number:
002348191
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
Yes
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:
Yes
Identifiers
Item #1 - Pkg Type:
CS
Item #1 - Device ID:
20801902226093
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
5
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10801902226096
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10801902226096
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 61594
Name: Central venous catheterization kit, short-term
Definition:
A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.
FDA Product Codes
FOZ
Catheter, intravascular, therapeutic, short-term less than 30 days
Premarket Submissions
Submission Number:
K071538
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
20
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
25
Storage Handling - Storage Handling Type:
Storage Environment Temperature