Amplion Care Assurance

Bootloader Firmware for Code Blue Station (CBS), Code Pink Station (CPS), Shower Station (SHS), Toilet Station (TS), Care Assurance Station (CAS), Duty Station (DS), Emergency Station (ES)

Registry build 21.09.26
1manufacturer
67catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code IQA
Manufacturer City Province Registered as Device types
Yuiyn HOO Industrial Limited Dong Guan Guangdong Contract manufacturer 3

Record

Regulatory record for Amplion Care Assurance
Listed by Amplion Clinical Communications, Inc.
FDA product code IQA
Device type System, Environmental Control, Powered
Device class Class 2
Regulation 21 CFR 890.3725
Premarket notification Exempt
Record published 2020-04-30
Record revised 2023-12-27 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number
Distribution end date 2023-12-20

Catalogue Numbers

Catalogue numbers for Amplion Care Assurance
Catalogue number Size Status
D-ZC-12-1 Withdrawn
F-SL-4A86-1 Withdrawn
S-CBA-188-1 Withdrawn
D-CAS-11-1 Withdrawn
D-ADD-X-2 Withdrawn
F-TS-B4AF-1 Withdrawn
F-SRC-1749-1 Withdrawn
F-BIS-63d6c96-1 Withdrawn
F-ES-C80A-1 Withdrawn
F-CDIS-D672-1 Withdrawn
D-BIS-13-1 Withdrawn
D-CDIS-20-6 Withdrawn
D-TS-13-1 Withdrawn
D-CDIS-12-2 Withdrawn
S-APP-238-1 Withdrawn
D-SRCNA-12-1 Withdrawn
F-CPS-B1BF-1 Withdrawn
D-CDIS-12-3 Withdrawn
F-CDIS-ae1e00c-1 Withdrawn
S-NCC-187-2 Withdrawn
D-DB-10-1 Withdrawn
F-CDIS-63d6c96-1 Withdrawn
S-CBA-187-1 Withdrawn
D-CDIS-20-4 Withdrawn
F-CDIS-A225-1 Withdrawn
D-DS-11-1 Withdrawn
S-SRC-187-1 Withdrawn
D-CDIS-12-4 Withdrawn
F-CDIS-126E-1 Withdrawn
F-SHS-3356-1 Withdrawn
D-TS-12-1 Withdrawn
D-ZL-11-1 Withdrawn
F-SRC-63d6c96-1 Withdrawn
D-PASNA-13-1 Withdrawn
S-NSC-241-1 Withdrawn
F-CAS-288A-1 Withdrawn
D-ES-10-1 Withdrawn
D-PAS-13-1 Withdrawn
F-DS-81B5-1 Withdrawn
D-ADD-X-1 Withdrawn
D-CDIS-20-2 Withdrawn
D-CDIS-20-3 Withdrawn
F-DS-F886-1 Withdrawn
D-CPS-10-1 Withdrawn
D-CDIS-20-7 Withdrawn
F-PAS-5730-1 Withdrawn
D-SRC-13R-1 Withdrawn
S-MGC-187-2 Withdrawn
S-NSC-2200-1 Withdrawn
D-SL-11-1 Withdrawn
D-PAS-12-1 Withdrawn
F-PAS-63d6c96-1 Withdrawn
F-CDIS-36D5-1 Withdrawn
D-SRC-14-1 Withdrawn
S-NCC-187-1 Withdrawn
D-CDIS-12-1 Withdrawn
S-MGC-187-1 Withdrawn
F-CDIS-326C-1 Withdrawn
F-CAS-63d6c96-1 Withdrawn
D-CDIS-20-1 Withdrawn
D-CDIS-20-5 Withdrawn
F-BIS-9551-1 Withdrawn
D-SRC-12-1 Withdrawn
D-MNC-X-1 Withdrawn
D-SHS-11-1 Withdrawn
F-SL-63d6c96-1 Withdrawn
S-APP-240-1 Withdrawn

Same Product Code

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Showing 12 of 819. All products under System, Environmental Control, Powered

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