Alpha Source Battery

8V 3.2AH SLA BATTERY with 4 PIN CONNECTOR

Registry build 21.09.26
5manufacturers in China registered for this device type
17catalogue 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 Alpha Source Battery
Listed by Alpha Source Inc.
FDA product code FRN
Device type Pump, Infusion
Device class Class 2
Regulation 21 CFR 880.5725
510(k) K922909
Record published 2019-06-20
Record revised 2023-05-03 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature -20 to 30 °C

Catalogue Numbers

Catalogue numbers for Alpha Source Battery
Catalogue number Size Status
AS30064 In distribution
AS36320 In distribution
AS35073 In distribution
AS10570 In distribution
AS10805 In distribution
AS10669-1 In distribution
AS35102 In distribution
AS11044 In distribution
AS10669 In distribution
AS35975 In distribution
AS35181 In distribution
AS36072 In distribution
AS10796-4 In distribution
AS36094 In distribution
AS10796 In distribution
AS35052 In distribution
AS36296-I 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
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
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