BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE

Set, I.v. Fluid Transfer

BAXTER HEALTHCARE CORPORATION

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Baxject Ii Hi-flow Needleless Transfer Device.

Pre-market Notification Details

Device IDK092318
510k NumberK092318
Device Name:BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
ClassificationSet, I.v. Fluid Transfer
Applicant BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN RD. MPGR-AL Mcgaw Park,  IL  60085
ContactValerie Followell
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-08-04
Decision Date2009-10-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00642621029383 K092318 000
00850025688871 K092318 000

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