Container, I.V.

Who Makes This Device Type in China?

3 of the 7 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Guangdong, Jiangsu and Beijing, and 2 other provinces.

Beijing L&Z Medical Technology Development Co., Ltd. Beijing
GRI Medical & Electronic Technology Co., Ltd. Zhejiang, contract manufacturer
Ming FAI Enterprise International Co., Ltd. Hong Kong
Ming FAI Industrial (Shenzhen) Co., Ltd. Guangdong, contract manufacturer
Wanying Health & Technology (Zhongshan) Co., Ltd. Guangdong, contract manufacturer
Yangzhou Weideli Trading Co., Ltd. Jiangsu, contract manufacturer
Yangzhou Xingwei Medical Technology Co., Ltd. Jiangsu, contract manufacturer

What Is FDA Product Code KPE?

Container, I.V. is FDA product code KPE, Class 2, 21 CFR 880.5025.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 2 clearances under this code; the FDA took a median of 221 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 62 recalls under this product code since 2005. None was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Process control (19), Process design (12) and Device Design (5). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Container, I.V.

BD SmartSite Bag 250ml

Catalogue number 11365-325-19, listed by Gilero, Inc, United States, under Container, I.V. 7 manufacturers in China are registered for this product code.

Container, I.V.

Container, I.V.

Additive Cap

Container, I.V.

Procedure Products Adapters

I.V. Universal Standard Tubing Spike

Container, I.V.

Right Way Medical

EVA TPN BAG FOR Parenteral Nutrition 1000ML

Container, I.V.

Exactamix

ExactaMix EMPTY EVA dual Chamber container with screw connectors, 3L

Container, I.V.

Empty IV Bag 250ml

Catalogue number 010073879000, listed by Merit Pharmaceutical, under Container, I.V. 7 manufacturers in China are registered for this product code.

Container, I.V.

Empty IV Bag 500ml

Catalogue number 099731320000, listed by Merit Pharmaceutical, under Container, I.V. 7 manufacturers in China are registered for this product code.

Container, I.V.

Nutrimix

Latex-Free Nutrimix Macro Vented Adapter PIN

Container, I.V.

Procedure Products Bag Spigot

Spigot, NON-Vented BAG 6" Tube

Container, I.V.

Medichoice

Decanter Bag For Aseptic Transfer Of Fluids From Flexible Containers Acrylonitrile-Butadiene-Styrene Plastic Sterile Not Made With Natural Rubber Latex MediChoice

Container, I.V.

BD SmartSite Bag 500ml

Catalogue number 11365-325-04, listed by Gilero, Inc, United States, under Container, I.V. 7 manufacturers in China are registered for this product code.

Container, I.V.

PAB®

Empty PAB® Partial Additive Bag, 150 mL

Container, I.V.

ALL-IN-ONE

ALL-IN-ONE Container, Empty EVA Container with Three Lead Transfer Set, 3000 mL Capacity

Container, I.V.

Nutri-Clamp

NUTRI-CLAMP Closure Device for use with Hospira Empty Containers with Attached Transfer Set

Container, I.V.

DLP®

IV Decanter 40040 Flex Tube-Clamp 20P 17

Container, I.V.

Microtek

C-FLO BAG Decanter

Container, I.V.

Vita

250 mL VITA EVA

Container, I.V.

Empty IV Bag 1000ml

Catalogue number MIVB100050, listed by Merit Pharmaceutical, under Container, I.V. 7 manufacturers in China are registered for this product code.

Container, I.V.

PMI

PMI Empty IV Bag 1000mL; 2 ports

Container, I.V.

Tamper Evident Additive Port Cap

"For use on the medication port of ICU Medical LifeCare ® to provide both visual evidence that medication has been added and tamper evidence once the device is closed. Packaged in…

Container, I.V.

Right Way Medical

1000 ml EVA bag with 2 detachable fill legs

Container, I.V.

Exactamix

EXACTAMIX Empty EVA Dual Chamber Container With Screw Connectors

Container, I.V.

Nutri-Clamp

NUTRI-CLAMP Closure Device FOR USE WITH NUTRIMIX-MACRO EMPTY CONTAINER WITH ATTACHED TRANSFER SET

Container, I.V.

Tamper Evident Clamp

PINNACLE® TPN Bag Tamper Resistant Clamps, smaller than 1 L

Container, I.V.

Medline Industries, Inc.

Decanter BTL 6IN

Container, I.V.

Hospira

3000 mL Empty Container with Attached Y-Transfer Set, Convertible Pins

Container, I.V.

ICU Medical

FleboCap™ Tamper Evident Medication Port Cover

Container, I.V.

ISO-MED

ISO-MED Sterile Empty EVA 2-Port Bags - 1000 mL 50/BX 4 BX/CS

Container, I.V.

B.braun

EVA Gravity Mixing Container, 2-lead Vented Transfer Set, 2000 mL

Container, I.V.

VisIV

VisCap Port Cover For VisIV Container

Container, I.V.

Disposable Infusion Bag for Parenteral Nutrition

The proposed device is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The…

Container, I.V.

GRI-BAG

6 catalogue numbers from 1000, listed by Laboratorios Grifols SA, under Container, I.V. 7 manufacturers in China are registered for this product code.

Container, I.V.

Additive

LATEX-FREE ADDITIVE HINGE CAP LifeCare Flexible Container

Container, I.V.

Secure®

Empty EVA Single Chamber Container With 5 Port Manifold Fill SET (10 Sets OF 5 Bags)

Container, I.V.

IMed Products

IMed EVA Gravity Bag, 1000mL, 3-Legs

Container, I.V.

Additive Cap

Additive Cap (Non-Sterile) for PAB® Bags

Container, I.V.

Stradis Medical, LLC

100mL EVA Bags, 2 Port

Container, I.V.

ChemoPlus

Yellow IVA Seals

Container, I.V.

Cormix

EMPTY EVA CONTAINER With Detachable 3 Leg Transfer Set

Container, I.V.

Acta Medical

500ml EVA bag with two way valve

Container, I.V.

Hometa

Empty EVA Bags 1000mL

Container, I.V.

Pinnacle®

PINNACLE® Dual Chamber Mixing Container, EVA Formulation, 1500 mL (1250+250)

Container, I.V.

EVA TPN Bags

TPN EVA Bag 2000ml with Female big bore connector - DEHP free

Container, I.V.

BD SmartSite Bag 100ml

Catalogue number 11365-325-18, listed by Gilero, Inc, United States, under Container, I.V. 7 manufacturers in China are registered for this product code.

Container, I.V.

Intravia

INTRAVIA Container, 1000 mL Capacity

Container, I.V.

Exactamix

250 mL ExactaMix EVA multiple (5 bags)

Container, I.V.

EcoFLX™ Empty Mixing Container

EcoFLX 2000mL Empty IV Mixing Container with 1 Spike Lead (EVA)

Container, I.V.

Steri-Tamp

Belly Button Bag Seals-13 mm vial Seals Green

Container, I.V.

Preferred Medical Products, LLC

Sterile Disposable BAG Decanter

Container, I.V.

eZSURE™

Empty Fluid Container 1000 ml Max Capacity (NFV Fill Port with Seal-Tab) (Non-Capped)

Container, I.V.

McKesson

BAG, EVA 2-PORT W/O Legs 500ML(50/CS)

Container, I.V.

MediBag

MediBag - 500 mL - Dual Port (Needleless and Spike Ports)

Container, I.V.

Unbranded

Decanter

Container, I.V.

Apex®

EVA Single-Chamber Final Containers 2000 mL

Container, I.V.

International Filter Products, Doing Business as IFP Medical

Sterile Empty EVA Pillow Bag, 3000 mL, 3 Ports, With One LF Port

Container, I.V.

Additive Port Cap

The Additive Port Cap provides visible evidence that medication has been added to a compatible Baxter IV container and tamper evidence after closure. It is used on the medication ports of…

Container, I.V.

Medline-Microtek

BAG Decanter II

Container, I.V.

Container, I.V.

EMPTY EVA CONTAINER With Detachable 3 Leg Transfer Set

Container, I.V.

PiSA BioPharm

Empty EVA Bags 1000 mL

Container, I.V.

ChemoPlus

Silver IVA Seals

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer