Device
INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, FX ADMINISTRATION CASSETTE, ROLLER CLAMP, NEEDLELESS Y-SITE AND SPIN MALE LUER LOCK
Manufacturer
EITAN MEDICAL LTD
EITAN MEDICAL LTD
Model: 12000-000-0044
DI: 17290109156016
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, FX ADMINISTRATION CASSETTE, ROLLER CLAMP, NEEDLELESS Y-SITE AND SPIN MALE LUER LOCK
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c0c4c2fe-b174-484b-8547-4f926d9ae9da
Distribution Status:
In Commercial Distribution
DUNS Number:
533108028
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:
Yes
Identifiers
Item #1 - Device ID:
27290109156013
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
20
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
17290109156016
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
17290109156016
Item #2 - Device ID Type:
Primary
Item #2 - Device ID 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:
K192860
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
5
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
30
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
5
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
30
Item #2 - Storage Handling Type:
Handling Environment Temperature