Port Access Infusion SET

Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through the Port Access Infusion Set are those generally used in…

Registry build 21.09.26

Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through the Port Access Infusion Set are those generally used in hospitals, and for chemotherapy.

5manufacturers in China registered for this device type
76catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FRN
Manufacturer City Province Registered as Device types
Sanmina Kunshan Jiangsu Contract manufacturer 15
Dongguan Honfield Precision Parts Co., Ltd. Zhangmutou, Dongguan Guangdong Contract manufacturer 8
JDI Electronics Factory Dongguan Guangdong Contract manufacturer 7
Zyno Electric & Machinery Ltd, Shanghai Shanghai Shanghai Contract manufacturer 1
Sterigenics Shanghai E Beam Ltd. Shanghai Shanghai Contract manufacturer 14

Record

Regulatory record for Port Access Infusion SET
Listed by Sb-Kawasumi Laboratories, Inc., Japan
FDA product code FRN
Device type Pump, Infusion
Device class Class 2
Regulation 21 CFR 880.5725
Record published 2016-09-20
Record revised 2024-02-28 (version 9)

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, manufacturing date
Sizes Needle gauge 19 to 22 G
Distribution end date 2023-12-31

Catalogue Numbers

Catalogue numbers for Port Access Infusion SET
Catalogue number Size Status
PI03090 Needle Gauge 19 G In distribution
PI01Y91 Needle Gauge 19 G In distribution
PI03000 Needle Gauge 20 G In distribution
PI04000 Needle Gauge 20 G In distribution
PI04091 Needle Gauge 19 G In distribution
PI01Y20 Needle Gauge 22 G In distribution
PI01Y90 Needle Gauge 19 G In distribution
PI03091 Needle Gauge 19 G In distribution
PI01Y91 Needle Gauge 19 G In distribution
PI04091 Needle Gauge 19 G In distribution
PI01Y03 Needle Gauge 20 G In distribution
PI01Y90 Needle Gauge 19 G In distribution
PI03090 Needle Gauge 19 G In distribution
PI01Y00 Needle Gauge 20 G In distribution
PI01Y00 Needle Gauge 20 G In distribution
PI03091 Needle Gauge 19 G In distribution
PI01Y21 Needle Gauge 22 G In distribution
PI04000 Needle Gauge 20 G In distribution
PI03001 Needle Gauge 20 G In distribution
PI03021 Needle Gauge 22 G In distribution
PI03001 Needle Gauge 20 G In distribution
PI04001 Needle Gauge 20 G In distribution
PI03020 Needle Gauge 22 G In distribution
PI04001 Needle Gauge 20 G In distribution
PI01Y01 Needle Gauge 20 G In distribution
PI01Y01 Needle Gauge 20 G In distribution
PI03021 Needle Gauge 22 G In distribution
PI01Y03 Needle Gauge 20 G In distribution
PI01Y20 Needle Gauge 22 G In distribution
PI03000 Needle Gauge 20 G In distribution
PI01Y21 Needle Gauge 22 G In distribution
PI03020 Needle Gauge 22 G In distribution
PI01Y23 Withdrawn
PI02091 Withdrawn
PI01090 Withdrawn
PI06000 Withdrawn
PI06021 Withdrawn
PI02Y23 Withdrawn
PI02Y01 Withdrawn
PI01000 Withdrawn
PI04023 Withdrawn
PI04093 Withdrawn
PI02Y03 Withdrawn
PI03023 Withdrawn
PI04021 Withdrawn
PI02Y90 Withdrawn
PI04090 Withdrawn
PI04020 Withdrawn
PI06001 Withdrawn
PI01091 Withdrawn
PI05091 Withdrawn
PI02001 Withdrawn
PI02090 Withdrawn
PI02Y21 Withdrawn
PI01021 Withdrawn
PI05000 Withdrawn
PI05020 Withdrawn
PI02021 Withdrawn
PI02Y91 Withdrawn
PI06020 Withdrawn
PI04003 Withdrawn
PI02Y93 Withdrawn
PI01001 Withdrawn
PI02020 Withdrawn
PI06090 Withdrawn
PI03093 Withdrawn
PI05021 Withdrawn
PI01020 Withdrawn
PI02000 Withdrawn
PI02Y20 Withdrawn
PI06091 Withdrawn
PI03003 Withdrawn
PI02Y00 Withdrawn
PI05001 Withdrawn
PI05090 Withdrawn
PI01Y93 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cadd ICU Medical, Inc 56
Flow Control Tubing GO Medical Industries PTY. Ltd. 39
Curlin Administration Set Zevex, Inc. 30
ambIT Summit Medical Products, Inc. 27
Beeline motIV Rex Pj Tech LLC 24
RMS Precision Flow Rate TubingTM Repro-Med Systems, Inc. 24
Medfusion ICU Medical, Inc 24
Volumat™ Line Fresenius Kabi AB 24
Outlook® B. Braun Medical Inc. 21
Alaris CareFusion 303, Inc 19
Alpha Source Battery Alpha Source Inc. 17
Plum ICU Medical, Inc 14

Showing 12 of 191. All products under Pump, Infusion

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