ProFusion Therapeutic Infusion Needle

The ProFusion Needle is a stainless-steel needle with a trocar tip and distal sideports for infusion. The device also consists of a proximal plastic hub for Luer lock connections.

Registry build 21.09.26
37manufacturers in China registered for this device type
13catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (9), Jiangsu (7), Shanghai (6). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GAA
Manufacturer City Province Registered as Device types
Hynaut Health Technology Co., Ltd. Qingdao Shandong Contract manufacturer 68
Jiangsu Caina Medical Co., Ltd. Jiangyin Jiangsu Contract manufacturer 20
Hantech Medical Device Co., Ltd. Cixi Zhejiang Contract manufacturer 18
Shanghai Kindly Enterprise Development Group Co., Ltd. Jiading Shanghai Contract manufacturer 11
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Taihu Anhui Contract manufacturer 8
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Ningbo Tianbo First AID Product Co., Ltd. Ningbo Zhejiang Repacker / relabeller 66
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Dongguan City Ruimi Gift Products Co Ltd Dongguan Guangdong Repacker / relabeller 62
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43
Joykey Industrial (Pinghu) Limited Pinghu Zhejiang Contract manufacturer 43

Showing 12 of 37. All 37 manufacturers in China registered for Needle, Aspiration And Injection, Disposable

Record

Regulatory record for ProFusion Therapeutic Infusion Needle
Listed by Cook Biodevice LLC
FDA product code GAA
Device type Needle, Aspiration And Injection, Disposable
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2021-03-04

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Sizes Needle gauge 19 to 25 G; length 2.5 to 25 cm

Catalogue Numbers

Catalogue numbers for ProFusion Therapeutic Infusion Needle
Catalogue number Size Status
PTIN-19-5.0 Needle Gauge 19 G In distribution
PTIN-21-25.0 Needle Gauge 21 G In distribution
PTIN-19-15.0 Needle Gauge 19 G In distribution
PTIN-19-10.0 Needle Gauge 19 G In distribution
PTIN-21-20.0 Needle Gauge 21 G In distribution
PTIN-25-5.0 Needle Gauge 25 G In distribution
PTIN-25-7.5 Needle Gauge 25 G In distribution
PTIN-19-7.5 Needle Gauge 19 G In distribution
PTIN-21-7.5 Needle Gauge 21 G In distribution
PTIN-25-2.5 Needle Gauge 25 G In distribution
PTIN-21-10.0 Needle Gauge 21 G In distribution
PTIN-21-15.0 Needle Gauge 21 G In distribution
PTIN-21-5.0 Needle Gauge 21 G In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 298
Anodyne Surgical Psi/Eye-Ko, Inc. 148
Zavation Zavation 121
Whiterose Micro Cannula UC Medical 38
Monoject Cardinal Health 33
MagniCore Cook Incorporated 29
Breast localisation needle Möller Medical GmbH 29
CytoCut M.D.L. S.R.L. 28
Chiba Needle Marked Remington Medical, Inc. 26
Walcott Rx Products Psi/Eye-Ko, Inc. 24
Breast Localization Needles Argon Medical Devices, Inc. 23
Fine Needle Aspiration Mermaid Medical A/S 22

Showing 12 of 183. All products under Needle, Aspiration And Injection, Disposable

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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