Avoset Subcutaneous set

GUDID 17290109152186

EITAN MEDICAL LTD

Electric infusion pump administration set, single-use

Primary Device ID	17290109152186
NIH Device Record Key	1ee22838-c953-42ad-abcb-24b2652aa8b5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Avoset Subcutaneous set
Version Model Number	12222-000-0013
Company DUNS	533108028
Company Name	EITAN MEDICAL LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290109152186 [Primary]
GS1	27290109152183 [Package] Package: [20 Units] In Commercial Distribution

FDA Product Code

FPA	Set, Administration, Intravascular

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-08-17
Device Publish Date	2023-08-09

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