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 ID: K092318
• 510k Number: K092318
• Device Name: BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
• Classification: Set, I.v. Fluid Transfer
• Applicant: BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN RD. MPGR-AL Mcgaw Park, IL 60085
• Contact: Valerie Followell
• Correspondent: Ned Devine; UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062
• Product Code: LHI
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2009-08-04
• Decision Date: 2009-10-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00642621029383	K092318	000
00850025688871	K092318	000