FDA.reportPublic FDA data

Fresenius Medical Care

Primary DI
04052882003637
Brand
Fresenius Medical Care
Company
FRESENIUS MEDICAL CARE SEATING (AUSTRALIA) PTY LTD
Model
T388
Device description
Manually Operated Treatment chair.
Published
2023-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FIAChair, Dialysis, Unpowered, Without Scales

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIAChair, Dialysis, Unpowered, Without ScalesGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052882003637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052882003637040528820036374052882003637

GMDN Terms#

Term, Definition table
TermDefinition
General examination/treatment chair, manualA manually-operated device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
752905877
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052882002883Fresenius Medical CareT600B2019-08-16
04052882003002Fresenius Medical Care T6882019-08-16
04052882002968Fresenius Medical Care T2002023-04-24
04052882003163Fresenius Medical CareT688B2022-06-23
04052882003651Fresenius Medical CareT5882022-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054416889Wal-Star, Inc.Wal-Star, Inc.FIA2025-08-20
00850054416858Wal-Star, IncWal-Star, Inc.FIA2024-08-07
00850054416865Wal-Star, IncWal-Star, Inc.FIA2024-08-07
00850054416872Wal-Star, IncWal-Star, Inc.FIA2024-08-07
00850054416841Wal-Star, Inc.Wal-Star, Inc.FIA2024-03-20
00850054416001Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416018Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416025Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416032Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416049Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416056Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416063Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416070Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416087Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416094Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416100Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416117Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416124Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416131Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416148Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416155Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416162Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416179Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416186Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-23
00850054416193Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-14
00850054416209Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-14
00850054416216Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-14
00850054416223Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-14
00850054416230Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-14
00850054416247Wal-Star, Inc.Wal-Star, Inc.FIA2023-07-14