FDA.reportPublic FDA data

R82

Primary DI
05715393012275
Brand
R82
Company
R82 A/S
Model
Flamingo Curo SIZE-1
Catalog number
882001
Published
2025-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INMChair, With Casters

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05715393012275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05715393012275057153930122755715393012275

GMDN Terms#

Term, Definition table
TermDefinition
Bath back rest/seatA device designed to support the back, and sometimes buttocks, of a patient (usually an adult) who is bathing in a bath (usually while being attended/assisted) to enable the patient to sit in an upright, and sometimes elevated, position in the bath. The patient is typically disabled, infirm, or undergoing medical treatment and cannot sit normally in a bath. The device may be a back rest only or a seat with an incorporated back rest, typically made of water-resistant or waterproof materials; it may be laid across the rim of the bath or secured to the bath. The device may be used in a hospital, institution, or home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
308022169
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
05715393055838R82x:panda shape infant L, w/belt91020000111042026-03-26
05715393078868R82x:panda shape infant L, no belt90020000030042026-03-26
05715393022809R82Addax SIZE 19120010002026-01-20
05715393022816R82Addax SIZE 19120010012026-01-20
05715393022823R82Addax SIZE 29120020002026-01-20
05715393022830R82Addax SIZE 29120020012026-01-20
05707292610744R82Cricket SIZE-1870431002022-10-12
05707292610751R82Cricket SIZE-2870432002022-10-12
05715393012282R82Flamingo Curo SIZE-28820022025-09-01
05715393012299R82Flamingo Curo SIZE-38820032025-09-01
05707292620989R82Scallop 1991051-1CR21F2022-10-12
05707292620996R82Scallop 1991051-1CR43F2022-10-12
05707292621009R82Scallop 2991051-2CR21F2022-10-12
05707292621016R82Scallop 2991051-2CR43F2022-10-12
05707292621047R82Scallop 3991051-3R21F2022-10-12
05707292621054R82Scallop 3991051-3R43F2022-10-12
05707292621085R82Scallop 4991051-4R21F2022-10-12
05707292621092R82Scallop 4991051-4R43F2022-10-12
05715393021949R82Crocodile, Size 1 AT86801AT2025-05-15
05715393021956R82Crocodile, Size 2 AT86802AT2025-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054040400612ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400629ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400636ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400643ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400650ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400667ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402074ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402081ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402098ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402104ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402111ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402128ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402210ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402227ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402234ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402241ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402258ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402265ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402272ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402289ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402296ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402302ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402319ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402326ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402333ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402340ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402357ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402364ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402371ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402388ADJUSTABLE TROLLIORMESA SRLINM2026-09-06