Accutrans Disposable Pressure Monitoring Kit

2 catalogue numbers from AT 4812-3 - 22-000948-21, listed by Bioptimal International Pte. Ltd., Singapore, under Transducer, Blood-Pressure, Extravascular. 7 manufacturers in China are registered for this product code.

Registry build 21.09.26
7manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (5), Zhejiang (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DRS
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Bioxin Medical Co., Ltd. Weihai Shandong Contract manufacturer 8
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
Orantech Inc. Shenzhen Guangdong Contract manufacturer 40
Zhejiang Haisheng Medical Device Co., Ltd. Shaoxing Zhejiang Contract manufacturer 21
Unimed Medical Supplies Inc Shenzhen Guangdong Contract manufacturer 15
Shenzhen Antmed Co., Ltd. Dongguan Guangdong Manufacturer 4

Record

Regulatory record for Accutrans Disposable Pressure Monitoring Kit
Listed by Bioptimal International Pte. Ltd., Singapore
FDA product code DRS
Device type Transducer, Blood-Pressure, Extravascular
Device class Class 2
Regulation 21 CFR 870.2850
Establishment Manufacturer
Record published 2021-05-06

Specifications

Specifications
MRI safety MR Conditional
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Store in dark cool dry places

Catalogue Numbers

Catalogue numbers for Accutrans Disposable Pressure Monitoring Kit
Catalogue number Size Status
AT 4812-3 – 22-000948-21 In distribution
AT W/O IFU(BNS) In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ICU Medical ICU Medical, Inc 381
Medex ICU Medical, Inc 225
Biotrans™ Pressure Monitoring Kits Bioptimal International Pte. Ltd. 134
Transpac™ ICU Medical, Inc 117
Antmed Shenzhen Antmed Co., Ltd. 96
Namic Navilyst Medical, Inc. 60
Namic Medline Industries, Inc. 58
Transpac™/Transtar™ ICU Medical, Inc 58
Merit Medical® Argon Critical Care Systems Singapore PTE. Ltd. 28
Centurion Centurion Medical Products Corporation 23
Transducer, Blood-Pressure, Extravascular Utah Medical Products, Inc. 22
Deltran Utah Medical Products, Inc. 22

Showing 12 of 145. All products under Transducer, Blood-Pressure, Extravascular

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