FDA.reportPublic FDA data

TR1000 with front closing armrests

Primary DI
07350016061018
Brand
TR1000 with front closing armrests
Company
Tr Equipment AB
Model
0521010
Device description
TR1000 with front closing armrests
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSALift, Patient, Non-Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350016061018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350016061018073500160610187350016061018

GMDN Terms#

Term, Definition table
TermDefinition
Bathing/changing table, mobileA raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off) mounted on a foldable frame with legs designed to support a recumbent patient for bathing, showering or changing. It is designed to be placed in an appropriate bathing area or where the patient can be given a body bath (washed by hand by assisting staff). The device is used primarily for a patient with a disability incapable of supporting themself in an upright position for bathing. It is designed to be portable or easily moved on wheels to different locations.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
354437485
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00735001606127TR3200-L Shower Trolley 2150*795cm, On board batteries, 4pcs castors with brake0532010-4B2023-12-11
07350016061261Hilo Bath TR 900 CWA US, Stainless Bathtub05192177-SS2023-12-11
07350016060035Ecoline with mixer, 50 MM DRAIN, H=80 CM051940322023-12-12
07350016060141TR1700 HI LO 230V incl. Mixer and shower051917012023-12-12
07350016060189TR900CW HI LO 230V Cleaning & Whirlpool051921702023-12-12
07350016060196TR900CWA HI LO 230V Cleaning, Autofill & Whirlpool051921752023-12-12
07350016061414TR900C HI LO 230V Cleaning GE051921622023-12-12
07350016061421TR900C HI LO 110V Cleaning US051921632023-12-12
07350016061438TR900CW HI LO 230V Cleaning & Whirlpool UK TMV3051921712023-12-12
07350016061445TR900CW HI LO 110V Cleaning & Whirlpool US051921722023-12-12
07350016061452TR900CW HI LO 230V Cleaning & Whirlpool GE051921732023-12-12
07350016061469TR900A HI LO 230V Autofill 051921552023-12-12
07350016061476TR900A HI LO 230V Autofill GE051921562023-12-12
07350016061483TR900A HI LO 230V Autofill UK TMV3051921572023-12-12
07350016061490TR900CA HI LO 230V Cleaning & Autofill 051921652023-12-12
07350016061506TR900CA HI LO 230V Cleaning & Autofill GE051921662023-12-12
07350016061513TR900CA HI LO 110V Cleaning & Autofill US051921672023-12-12
07350016061520TR900CWA HI LO 230V Cleaning, Autofill & Whirlpool GE051921762023-12-12
07350016061537TR900CWA HI LO 110V Cleaning, Autofill & Whirlpool US051921772023-12-12
07350016061544TR900CW Fixed height 230V051922702023-12-12

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