Citadel Plus - Medical Bed - CITADEL PLUS - USA - Arjohuntleigh AB

Duns Number:355804758

Device Description: Medical Bed - CITADEL PLUS - USA

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More Product Details

Catalog Number

-

Brand Name

Citadel Plus

Version/Model Number

FXX11C1B1AMABA

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FNL

Product Code Name

BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Record Status

Public Device Record Key

588862a6-f3dd-47cd-b662-fd7b762aaf9c

Public Version Date

September 19, 2022

Public Version Number

1

DI Record Publish Date

September 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARJOHUNTLEIGH AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 420
2 A medical device with a moderate to high risk that requires special controls. 840