Product Code: LHI

Products Classified as LHI

2655

Set, I.v. Fluid Transfer

Intravascular Administration Set.

Total Product Life Cycle (TPLC) Devices

2655

Set, I.v. Fluid Transfer

Intravascular Administration Set.

FDA Consensus Standards

• Set, I.V. Fluid Transfer [31768]: 21 CFR §880.5440 🔎
• Set, I.V. Fluid Transfer [31780]: 21 CFR §880.5440 🔎
• Set, I.V. Fluid Transfer [30975]: 21 CFR §880.5440 🔎
• Set, I.V. Fluid Transfer [38415]: 21 CFR §880.5440 🔎
• Set, I.V. Fluid Transfer [30988]: 21 CFR §880.5440 🔎
• Set, I.V. Fluid Transfer [30984]: 21 CFR §880.5440 🔎
• Set, I.V. Fluid Transfer [30202]: 21 CFR §880.5440 🔎
• Set, I.V. Fluid Transfer [38414]: 21 CFR §880.5440 🔎

Pre-market Notifications for LHI

K221406	Vented Vial Transfer Pin	Jiangsu Caina Medical Co., Ltd.
K213513	Vented Vial Adapter 20mm	West Pharma Services IL, Ltd.
K212525	Advcare Vial Direct To Bag (VDB) Needle-free Admixture Devices	Advcare Medical
K212530	IVX Fluid Transfer Set	Omnicell, Inc.
K212445	Freeflex+ Transfer Adapter	Fresenius Kabi AG
K202732	SOL-CARE IV Bag Safety Connector	Sol-Millennium Medical Group
K201469	Mini Spike Plus 6/8R	B. Braun Medical Inc.
K201415	Vial2Bag Advanced 20mm Admixture Device	West Pharmaceutical Services AZ, Inc.
K192154	Rio Vial-to-Bag Drug Reconstitution Device	ICU Medical
K190816	Vial Adapter Ø20 Mm , Vial Adapter Ø13 Mm	Avenir Performance Europeenne Medical (APEM)
K190149	Vial Adapter Ø20 Mm	Avenir Performance Europeenne Medical (APEM)
K183187	Nextaro Transfer System, Nextaro Va	SFM Medical Devices GmbH
K182819	Decanting Device	Gcmedica Enterprise Ltd., (WUXI)
K173577	Guarded Luer Connector	International Medical Industries Inc.
K172884	Arisure Closed Vial Adapter	Yukon Medical

Global Unique Device Identification Database

• 10304040017040: Set, i.V. Fluid transfer
• 10304040016814: Set, i.V. Fluid transfer
• 00642621029383: Set, I.V. Fluid Transfer
• 50642621003944: Set, I.V. Fluid Transfer
• 00616784706238: Set, I.V. Fluid Transfer
• 00616784706139: Set, I.V. Fluid Transfer
• 00616784706030: Set, I.V. Fluid Transfer
• 00616784705439: Set, I.V. Fluid Transfer
• 00616784705330: Set, I.V. Fluid Transfer
• 00616784705231: Set, I.V. Fluid Transfer
• 00616784705132: Set, I.V. Fluid Transfer
• 00616784705033: Set, I.V. Fluid Transfer
• 00616784704937: Set, I.V. Fluid Transfer
• 00616784704838: Set, I.V. Fluid Transfer
• 00616784703732: Set, I.V. Fluid Transfer

Maude Adverse Events

2000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-31
TUBE SET, STD VOL, STER	BAXTER HEALTHCARE CORPORATION	2020-03-31
1000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-31
2000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-31
2000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-31
500 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-31
1000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-31
250 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-31
VIAL-MATE RECONSTITUTION DEVICE	BAXTER HEALTHCARE CORPORATION	2020-03-31
4000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-31
2000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-31
500 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-30
VIAL-MATE RECONSTITUTION DEVICE	BAXTER HEALTHCARE CORPORTION	2020-03-30
2000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-30
EVA TPN 1000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-30
500 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-30
3000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-30
1000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-30
2000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-30
VIAL-MATE RECONSTITUTION DEVICE	BAXTER HEALTHCARE CORPORATION	2020-03-30
500 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-30
500 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-30
3000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-27
2000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-27
EXACTAMIX 500 EVA CONTAINER	BAXTER HEALTHCARE CORPORATION	2020-03-26
EXACTAMIX 500 EVA CONTAINER	BAXTER HEALTHCARE CORPORATION	2020-03-26
EXACTAMIX 500 EVA CONTAINER	BAXTER HEALTHCARE CORPORATION	2020-03-26
EXACTAMIX 500 EVA CONTAINER	BAXTER HEALTHCARE CORPORATION	2020-03-26
500 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-26
VALVE SET, EM2400	BAXTER HEALTHCARE CORPORATION	2020-03-26
VENTED MICRO VOL.INLET, N/S	BAXTER HEALTHCARE CORPORATION	2020-03-26
3000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-26
EVA TPN 3000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-26
VENTED HIGH VOL. INLET, N/S	BAXTER HEALTHCARE CORPORATION	2020-03-26
500 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-26
EVA TPN 3000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-26
EVA TPN 3000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-26
500 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-25
EVA TPN 3000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-25
EVA TPN 3000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-25
3000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-25
500 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-24
VALVE SET, EM2400	BAXTER HEALTHCARE CORPORATION	2020-03-24
TUBE SET, STD VOL, STER	BAXTER HEALTHCARE CORPORATION	2020-03-24
2000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-24
TUBE SET, STD VOL, STER	BAXTER HEALTHCARE CORPORATION	2020-03-23
500 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-23
EVA TPN 1000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-23
1000 ML TPN BAG	BAXTER HEALTHCARE CORPORATION	2020-03-23
TUBE SET, STD VOL, STER	BAXTER HEALTHCARE CORPORATION	2020-03-23