ASP Aeroflex™

ASP AEROFLEX™ Automatic Endoscope Reprocessor

Registry build 21.09.26
1manufacturer
10catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FEB
Manufacturer City Province Registered as Device types
Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 5

Record

Regulatory record for ASP Aeroflex™
Listed by Advanced Sterilization Products Services Inc.
FDA product code FEB
Device type Accessories, Cleaning, For Endoscope
Device class Class 2
Regulation 21 CFR 876.1500
510(k) K181472
Record published 2019-07-31
Record revised 2025-12-19 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number, manufacturing date, serial number
Storage Storage environment temperature 15 to 30 °C; Storage environment humidity 10 to 85 % RH

Catalogue Numbers

Catalogue numbers for ASP Aeroflex™
Catalogue number Size Status
9119014 In distribution
9119012 In distribution
9119015 In distribution
9119013 In distribution
28000 In distribution
9119011 In distribution
9119028 In distribution
0118801 In distribution
9119024 In distribution
0119001 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medivators Hookup Medivators Inc 333
Evotech™ Advanced Sterilization Products Services Inc. 104
Connecting Tube Olympus Medical Systems Corp. 47
Accessories, Cleaning, For Endoscope Steris Corporation 39
Accessories, Cleaning, For Endoscope Pentax of America, Inc. 24
Accessories, Cleaning, For Endoscope Richard Wolf Gmbh 16
Scope Buddy Plus Tubing Medivators Inc 9
Accessories, Cleaning, For Endoscope Corporation Steris Canada 8
Scope Assist Flushing Sink (Safs) Wassenburg Medical, Inc. 6
System 83 Plus Wassenburg Medical, Inc. 4
Leak Test AIR Tube Olympus Medical Systems Corp. 4
Sugi Questalpha GmbH & Co. KG 4

Showing 12 of 48. All products under Accessories, Cleaning, For Endoscope

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