FDA.reportPublic FDA data

ADS

Primary DI
06971608311505
Brand
ADS
Company
Guangzhou Ajax Medical Equipment Co., Ltd.
Model
ACA5
Published
2025-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250164000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250164000Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.2025-08-14FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971608311505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971608311505069716083115056971608311505

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547897476
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971608310096ADSAJ212026-04-22
06971608310140ADSAJ272026-04-22
06971608311758ADSAJX1002026-04-22
06971608311765ADSAJX2002026-04-22
06971608311802ADSAJX3002026-04-22
06971608311819ADSAJX4002026-04-22
06971608311826ADSAJX5002026-04-22
06971608311833ADSAJX6002026-04-22
06971608311840ADSAJX7002026-04-22
06971608312533ADSThor2026-04-22
06971608312540ADSThor-s2026-04-22
06971608312557ADSEOS Extraoral Suction System2026-04-22
06971608312564ADSOptima 3502026-04-22
06971608312571ADSEOS Plus2026-04-22
06971608310003ADSAJ102023-11-02
06971608310010ADSAJ112023-11-02
06971608310027ADSAJ122023-11-02
06971608310034ADSAJ152023-11-02
06971608310041ADSAJ162023-11-02
06971608310058ADSAJ172023-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05902533549511Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-05-15
07629999825710EnbioEnbio Group AGFLE2026-05-12
07629999932531EnbioEnbio Group AGFLE2026-05-12
06972615108058icanclaveNingbo Ican Machines Co., Ltd.FLE2026-04-26
07640397422271BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422288BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422295BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422301BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422318BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422325BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07629999282957Enbio-Autoclave Control FirmwareEnbio Group AGFLE2026-03-02
07629999900769Enbio PRO (ver. USA/CAN)Enbio Group AGFLE2026-03-02
05902533549214Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-02-16
00860014827310Lucas LifecareLucas Lifecare, LLCFLE2026-01-28
05902533549115Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-01-16
05902533549122Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-01-16
07640397421731STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
07640397421748STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
07640397421755STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
07640397421793STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
06972615108003icanclaveNingbo Ican Machines Co., Ltd.FLE2025-12-19
05904165664280EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
05904165664303EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
05904165664310EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
05902533548842Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-15
05902533548828Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
05902533548835Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
05902533548873Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
05902533549023Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
07640397421410STATIM 2000 G4 Cassette AutoclaveDent4You AGFLE2025-07-22