FDA.report

Maxi Sky 2

Primary DI
05056097356761
Brand
Maxi Sky 2
Company
Arjohuntleigh AB
Model
MS011
Device description
Maxi Sky 2, 2F CSTAT RADIUS WH - Ceiling Lift - Safe working load of 600 lb / 272 kg.
Published
2022-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FSALift, Patient, Non-Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05056097356761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05056097356761050560973567615056097356761

GMDN Terms

TermDefinition
Mobile patient lifting system, electrically-poweredAn electrically-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort. Also known as a patient hoist, it typically consists of a support base on wheels with a motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, a patient holding device (e.g., a sling, holder or a frame). It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom.

Sterilization Methods

Method

Regulatory Flags

DUNS number
355804758
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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05056097364049SARA FLEXTSS.503WTSS.503W2022-09-03
05056097369921SARA FLEXTSS.501WTSS.501W2022-09-03
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