ambIT

Cassette - Filter, Spike with Yellow Striped Tubing, and Neuraxial Connector

Registry build 21.09.26
5manufacturers in China registered for this device type
27catalogue 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 ambIT
Listed by Summit Medical Products, Inc., United States
FDA product code FRN
Device type Pump, Infusion
Device class Class 2
Regulation 21 CFR 880.5725
Record published 2016-09-09
Record revised 2024-08-07 (version 7)

Specifications

Specifications
MRI safety MR Unsafe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date, serial number
Storage Storage environment temperature -25 to 70 °C
Packaging Pack of 20, pack of 10, pack of 40

Catalogue Numbers

Catalogue numbers for ambIT
Catalogue number Size Status
220426 In distribution
220461 In distribution
220476 In distribution
220571 In distribution
220517Y In distribution
220244 In distribution
220140Y In distribution
220267 In distribution
220517 In distribution
220437 In distribution
220332 In distribution
220452 In distribution
220523 In distribution
220501 In distribution
220534 In distribution
220546 In distribution
220540 In distribution
220266 In distribution
220514 In distribution
220140 In distribution
220266Y In distribution
220140B In distribution
220139 In distribution
220326 In distribution
220468 In distribution
220514Y In distribution
220572 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Port Access Infusion SET Sb-Kawasumi Laboratories, Inc. 76
Cadd ICU Medical, Inc 56
Flow Control Tubing GO Medical Industries PTY. Ltd. 39
Curlin Administration Set Zevex, Inc. 30
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