FDA.report

Shuttle Series B - Standard

Primary DI
00845699001064
Brand
Shuttle Series B - Standard
Company
SIZEWISE RENTALS, L.L.C.
Model
T1000-ST
Published
2019-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FMRDevice, Transfer, Patient, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845699001064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845699001064008456990010648456990010640845699001064

GMDN Terms

TermDefinition
Mobile bariatric examination/treatment chair, electricA mobile (on wheels) electronic device designed to support in a seated position an ambulatory or non-ambulatory bariatric (obese) patient, whose body mass exceeds the safe working load of a standard hospital/institution chair (e.g., around 350 kg), for examination/treatment. It incorporates a heavy-duty framework, extra wide seat-support for the patient, and an integrated rechargeable battery pack that powers electromotive functions (e.g., raise/lower/tilt/adjustment functions, motorized wheels). It is designed to be moved by healthcare professional for patient transport to a site for patient support without transfer during outpatient examination/treatment (e.g., surgical, dental, ENT).

Sterilization Methods

Method

Regulatory Flags

DUNS number
967025602
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
false
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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00845699002658SizewiseADP ROLAL35882024-09-20
00845699002672SizewiseIMLAL 35802024-09-20

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