I.V. Start Kit

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Fujian and Guangdong, and 2 other provinces: 7 hold an FDA registration. 1 is a contract manufacturer.

Amsino Medical (Kunshan) Co., Ltd. Jiangsu, contract manufacturer
Conod Medical Co., Limited Jiangsu, contract manufacturer
Hubei Lanbin Medical Group Co., Ltd. Hubei, contract manufacturer
Jiangsu NEW Pentastar Medical Products Co., Ltd. Jiangsu
Xiamen ANK Hygiene Care Product Co., Ltd. Fujian
Yafho BIO-Technology Co., Ltd. Guangdong
Zibo Qichuang Medical Products Co., Ltd. Shandong

What Is It?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

How Is LRS Classified?

I.V. Start Kit is FDA product code LRS, Class 2, 21 CFR 880.5200.

How Does It Reach the US Market?

The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.

What Has Gone Wrong With It?

The FDA has recorded 165 recalls under this product code since 2009. None was by a company in China. 5 are Class I, the most serious grade.

The root causes the FDA records most often are Material/Component Contamination (60), Nonconforming Material/Component (39) and Packaging process control (20). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Comfort Release

IV Start Kit with Comfort Release GB110 & GB107

Intravenous-Intraosseous Kit (TMK-IV/IO), Black

Catalogue number 01323BK, listed by Altitude Technologies Inc., under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

IV Start Kit

KIT, IV Start - Custom, OFO

Nexiva™

Kit: IV 100/Cs PILOT

Arrow

Catalogue number IPNB00172, listed by Teleflex Medical LLC, United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

Monoject

2 catalogue numbers from 80500, listed by Cardinal Health, United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

Intravenous-Intraosseous Kit (TMK-IV/IO), Coyote Brown

Catalogue number 01323CB, listed by Altitude Technologies Inc., under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

Intravenous-Intraosseous Kit (TMK-IV/IO), Refill, Contents Only

Catalogue number 01323REF, listed by Altitude Technologies Inc., under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

IV Start Kit W/catheter, 18ga

Catheter, intravascular, therapeutic, short-term - less than 30 days. Contains the items needed for starting and securing a saline lock for extremity venous cannulation.

DeRoyal

Fletcher Allen Healthcare Neuro Kit

Invenio

IV Start KIT W/CHG 30/CS Rimaco Label

AMSure® IV Start Kit

1 Pre-Filled Normal Saline Flush Syringe 10 cc(sterilized)(China) 1 Extension set(sterilized)(China) 2 Alcohol prep pad(sterilized)(China) 1 Patient label(Non-sterile)(China) 1 Gauze, 2'' x…

IMed Products

Infusion Set Up Kit - Custom

BD IV Start Pak

IV Start PAK W/PVP, Tegaderm, MED Gloves

Medical Shipment

IV Start Kit w/ CHG, Transparent Dressing & Nitrile Gloves, Sterile, 1/each

BBraun

9 catalogue numbers from 375198, listed by Medical Action Industries, Inc., United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

Avid Medical Trucustom

2 catalogue numbers from VAMM041, listed by Medical Action Industries, Inc., United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

Clik-FIX

IV Start Kit with Clik-FIX All 'n One Peripheral IV Securement

Regard

2 catalogue numbers from 405218REG, listed by Medical Action Industries, Inc., United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

Other

Catalogue number DYNDV2487, listed by Medline Industries, Inc., United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

IV Start Kit

IV Start Kit, Stretch Vinyl Gloves, Sterile, 1 Tourniquet (3/4" x 18"), 2 Gauze Sponge (2" x 2", 8 Ply), 1 ID Label, 1 Pair of PVC Gloves in paper wrap, 1 Transparent Dressing, 1 Tape (3/4"…

Centurion Medical Products Corp

Floor Ultrasound Guided IV SEC

Easycare

IV Start Kit w/3M™ Tegaderm™ #1633 Split Tail & PDI Prevantics® Swab

ACS

IV Start KIT NON-Sterile

IV Start Kit

IV Start Kit is a single-use, disposable procedure packs with various combination of components, such as adhesive dressing, underpad, gauze, label, tourniquet, and sterile field. The…

Regard™

Ultrasound IV Start KIT

Tacy Medical Inc

Catalogue number TM.769VG-2, listed by Medical Action Industries, Inc., United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

Aero-Med

Complete IV Start Kit

BD IV Start Pak, BD Persist

Ivss RED Persist WO Tegaderm MED GLV DRP

Health Care Technology

4 catalogue numbers from HCT5525PX-2, listed by Medical Action Industries, Inc., United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

Latin Health

Catalogue number LH_267014, listed by Medical Action Industries, Inc., United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

Regard™

IV Start KIT-Split Tail Dressing 1.5ML Chloraprep

80-110-10 Saline Lock Kit Case of 10

The Mojo® Saline Lock Kit allows for quick and effective extremity venous cannulation under the most demanding conditions in one complete set. It contains the necessary items for starting…

Intravenous Infusion Starter SET Case of 20

The IV Infusion Starter Set allows for quick and effective extremity venous cannulation under the most demanding conditions in one complete set. It contains the necessary items for starting…

Health Care Technology

2 catalogue numbers from HCT5525PX-V, listed by Vygon Corp., United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

NAR Kit

KIT, Saline Lock - Needleless

Intravenous Infusion Starter SET

18 GA Catheter 1 ea 20 GA Catheter 1 ea Saline Flush (5cc pre-filled syringe) 1 ea Povidone Prep Pad 1 ea Alcohol Prep Pad 2 ea IV Administration Set 1 ea Needle Free Valve with Luer Lock 1…

Vygon

Needleless Connector Change Tray

B. Braun

Catalogue number 375212, listed by Medical Action Industries, Inc., United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

MedStream

IV Start KIT - Custom

Henry Schein

IV Start Kit w/ PVP & Alcohol

Medline

IV START KIT w/ ChloraScrub Mini-Swab

Trinity Sterile, Inc.

Pediatric IV Start KIT

Administration Set

Administration set for infusion containing 2 alcohol swabs, 1 infusion set, 2 gauze pads, and 2 bandages.

Forward

Field Safety 20G IV Start Kit w/Flush

Curaplex

Tegaderm IVDress, ClearTape, Alcohol PrepPads, PVP Swabstick, GauzeSponge, Tourniquet, Patient Label

MediChoice

Kit IV Start Includes 1 Flex Blister With Lid 1 Tegaderm Dressing 2.5X2.75 2 Gauze 2X2 1 Chloraprep Frepp Insert 1 Chloraprep Frepp 1.5ml Applicator 1 Tourniquet 0.75X18 Rolled 1 Transpore…

McKesson

I.V. Start Kit, TEGADERM™ DRESSING, PREVANTICS® ANTISEPTIC SWAB PAD

Busse Hospital Disposables

7 catalogue numbers from 1293, listed by Robert Busse & Co., Inc., United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

Motion Medical Distributing

#1301 IV Start Kit Contents: (1) Tegaderm #1624W, (1) Transpore Tape #1527, (1) Tourniquet L/F, (1) Sponge 2x2 2/Pk, (2) Prevantics Prep Pad, (1) ChloraPrep 1.5mL, (1) Extension Set 8", (1)…

LSL Healthcare

83 catalogue numbers from 3289FA, listed by Lsl Industries, Inc., United States, under I.V. Start Kit. 7 manufacturers in China are registered for this product code.

Stradis Medical, LLC.

CAP Dressing Change KIT

Medline Industries, Inc.

IV Start KIT W/ STD Bore EXT Tube

Saline Lock KIT

The Mojo® Saline Lock Kit allows for quick and effective extremity venous cannulation under the most demanding conditions in one complete set. It contains the necessary items for starting…

Medical Action Industries

NA NA Combo No Disposable/Sngle Use FDA Class N/A Kit No Latex Natural Rubber LTX Over The Counter Rx Sterile

Medline

KIT IV Start SHC Securement Tegaderm DRG

PremierPro

IV Start Kit Pediatric: Tegaderm™ 1624, ChloraPrep® Frepp® 1.5ml, Saline Wipe, Scissor 4.5" Sharp Blunt, Med Nitrile Gloves, Steristrip .25"x4" 5/card, Orange Tourniquet .75"x18"

Cardinal Health

Ultrasound Guided IV Start KIT

Centurion

IV Start KIT W/Sorbaview Shield Dressing

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