B-Smart

B-Smart nerve-block injection pressure manometer

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code CAZ
Manufacturer City Province Registered as Device types
Jiangsu Caina Medical Co., Ltd. Jiangyin Jiangsu Contract manufacturer 20

Record

Regulatory record for B-Smart
Listed by HMC Premedical SPA
FDA product code CAZ
Device type Anesthesia Conduction Kit
Device class Class 2
Regulation 21 CFR 868.5140
510(k) K031128
Record published 2016-10-04
Record revised 2018-07-06 (version 3)

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
Packaging Base box of 25, carton box of 11

Catalogue Numbers

Catalogue numbers for B-Smart
Catalogue number Size Status
BS015-30 In distribution

Same Product Code

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Product Sold by Catalogue numbers
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Contiplex® B. Braun Medical Inc. 34
Stimulong Sono Pajunk Gmbh Medizintechnologie 27

Showing 12 of 109. All products under Anesthesia Conduction Kit

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