AP411-01- MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE, SLIDE CLAMP, NEED

Basic Information

• Brand Name: AP411-01- MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE, SLIDE CLAMP, NEED
• Primary DI: 17290109153190
• Version / Model: 12003-000-0078
• Catalog Number: 12003-000-0078
• Company Name: EITAN MEDICAL LTD
• Labeler DUNS: 533108028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-15
• Public Version: 2
• Public Version Date: 2022-11-23
• Public Version Status: Update
• Public Device Record Key: 1c63a357-7e6e-4ccc-a32f-2a826d1a700a

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35833	Electric infusion pump administration set, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27290109153197	GS1	Cardboard box	30	In Commercial Distribution
Primary	17290109153190	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K192860	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius