FDA.report

Care bed AURA

Primary DI
04065848000083
Brand
Care bed AURA
Company
Malsch GmbH
Model
1
Device description
The medical care bed with electric drives is an advanced bed specifically designed for use in medical facilities such as hospitals, nursing homes, and rehabilitation centers. It offers a range of features and characteristics aimed at improving patient comfort, safety, and quality of care. Features and Specifications: Electric Height Adjustment - Adjustable Sleeping Surface - Integrated Side Rails - Integrated Control Unit - Robust Construction. The Care bed AURA provides a safe, comfortable, and functional solution for the care and treatment of patients in medical facilities. It complies with all relevant safety standards and regulations and helps make the caregiving process more efficient and effective.
Published
2024-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications

CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04065848000083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04065848000083040658480000834065848000083

GMDN Terms

TermDefinition
Electrical assistive bedA mains electricity (AC-powered) bed designed for a person with a disability and operated by the occupant and/or an attendant using controls that activate electrically-powered motors that adjust the positioning of the mattress. It may have one or more sections of the mattress support platform that can be adjusted in height and/or angle.

Sterilization Methods

Method

Contacts

PhoneEmail
+496626915100info@bettenmalsch.de

Regulatory Flags

DUNS number
331567482
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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