Sapphire MT Infusion Kit 16 – US

GUDID 17290109155095

EITAN MEDICAL LTD

Bedside infusion pump, single-channel
Primary Device ID17290109155095
NIH Device Record Keyb3ad90d4-4a18-4503-8cd0-e825870f3718
Commercial Distribution StatusIn Commercial Distribution
Brand NameSapphire MT Infusion Kit 16 – US
Version Model Number17000-028-1039
Company DUNS533108028
Company NameEITAN MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290109155095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-04
Device Publish Date2024-02-25

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