Fresenius Medical Care - Electric Treatment chair for use in dialysis, day - FRESENIUS MEDICAL CARE SEATING (AUSTRALIA) PTY LTD

Duns Number:752905877

Device Description: Electric Treatment chair for use in dialysis, day surgery and oncology applications. The c Electric Treatment chair for use in dialysis, day surgery and oncology applications. The chair is intended for patients with weight not exceeding 660 lbs (300kg)

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More Product Details

Catalog Number

-

Brand Name

Fresenius Medical Care

Version/Model Number

T688B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

INO

Product Code Name

Chair, Positioning, Electric

Device Record Status

Public Device Record Key

c269d0d7-0314-45b9-8517-7ad3b1e03b1d

Public Version Date

September 27, 2022

Public Version Number

2

DI Record Publish Date

June 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FRESENIUS MEDICAL CARE SEATING (AUSTRALIA) PTY LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4