Ascope BronchoSampler™Specimen Sampling System – Single Use

Ambu aScope BronchoSampler A Single-use, sterile and closed-loop system for bronchoscopic specimen sampling. Set included 2 container, 1 interface for sampling and 1 suction adapter. For…

Registry build 21.09.26

Ambu aScope BronchoSampler A Single-use, sterile and closed-loop system for bronchoscopic specimen sampling. Set included 2 container, 1 interface for sampling and 1 suction adapter. For integration with Ambu aScope 4 Broncho. Container volume 30ml, ETO sterilisation method. Minimum ordering is 5 pcs = 1 box

2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (1), Zhejiang (1).

Chinese manufacturers registered for FDA product code CBC
Manufacturer City Province Registered as Device types
Smartdata Suzhou Co., Ltd. Suzhou Jiangsu Contract manufacturer 11
Yuyao Jiahua Medical Appliance, Co., Ltd. Yuyao Zhejiang Manufacturer 5

Record

Regulatory record for aScope BronchoSampler™Specimen Sampling System – Single Use
Listed by Ambu A/S, Denmark
FDA product code CBC
Device type Bottle, Collection And Trap, Breathing System (Uncalibrated)
Device class Class 2
Regulation 21 CFR 880.6740
Establishment Specification developer, Private-label distributor, Manufacturer, Exporter
Premarket notification Exempt
Record published 2019-01-30
Record revised 2026-01-30 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Storage environment temperature 10 to 40 °C; Storage environment humidity 30 to 85 % RH; Handling environment temperature 10 to 40 °C
Packaging Pack of 5, pack of 8
Distribution end date 2023-04-12

Catalogue Numbers

Catalogue numbers for aScope BronchoSampler™Specimen Sampling System – Single Use
Catalogue number Size Status
480200000 Withdrawn

Same Product Code

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Product Sold by Catalogue numbers
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andorate® ThomasTrap™ Polyp Trap with Two Removable Chambers GA Health Company Limited 2
Andorate® Single Chamber Polyp Trap GA Health Company Limited 1
Single Chamber Polyp Trap GA Health Company Limited 1
Polyp Trap with Two Removable Chambers (Non-sterile) GA Health Company Limited 1
Jedmed Jedmed Instrument Company 1
Four Chamber Polyp Trap GA Health Company Limited 1
Single Chamber Polyp Trap (Non-sterile) GA Health Company Limited 1
Capture Diversatek Healthcare Inc 1

Showing 12 of 17. All products under Bottle, Collection And Trap, Breathing System (Uncalibrated)

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