Model: DKSP-10014-000
DI: 00850017421615
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
iiSure Infusion Set (10 pack)
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2a63a3d4-38e6-4692-87a6-774355f7cbb1
Distribution Status:
In Commercial Distribution
DUNS Number:
119070341
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850017421615
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35833
Name: Electric infusion pump administration set, single-use
Definition:
A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.
FDA Product Codes
FPA
Set, Administration, Intravascular
Premarket Submissions
Submission Number:
K243841
Supplement Number:
000