FDA.reportPublic FDA data

Atlantis

Primary DI
06975084500705
Brand
Atlantis
Company
XIAMEN ATLANTIS MFC CO.,LTD
Model
B536U
Published
2026-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975084500705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975084500705069750845007056975084500705

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric home bedA mains electricity (AC-powered) motorized bed designed to be used in the home by a patient for rest/sleep, and that provides the occupant with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard and a remote control to operate the electrical motors. The device typically raises the torso and/or legs to various heights. It may also include a heatable mattress and physical therapy pulsators.

Regulatory Flags#

DUNS number
529307505
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972077023135CostcareL350C2026-09-24
06972077023142CostcareL400C2026-09-24
06972077023159CostcareL400XC2026-09-24
06972077023166CostcareL440C2026-09-24
06972077023722CostcareL205B2026-09-24
06972077023739CostcareL205T2026-09-24
06972077023814CostcareL2702026-09-24
06972077023883CostcareBPR4102026-09-24
06972077024002CostcareL430C2026-09-24
06972077024033CostcareL2502026-09-24
06972077024125CostcareBPR180B2026-09-24
06972077024132CostcareBPR240B2026-09-24
06972077024149CostcareBPR250B2026-09-24
06972077024156CostcareBPR400B2026-09-24
06972077024163CostcareBPR410B2026-09-24
06972077024316CostcareBPM3002026-09-24
06972077024323CostcareBPM3502026-09-24
06972077024750CostcareL5102026-09-24
06972077024767CostcareL511X2026-09-24
06972077024774Evermed705502026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828197144MBA-BE,S37,INL,1'CURBELL MEDICAL PRODUCTS, INC.FNL2026-10-15
00840828197151MBA-BE,S37,INL,6'CURBELL MEDICAL PRODUCTS, INC.FNL2026-10-15
00840828197168MBA-BE,P37,INL,1'CURBELL MEDICAL PRODUCTS, INC.FNL2026-10-15
00840828197175MBA-BE,P37,INL,6'CURBELL MEDICAL PRODUCTS, INC.FNL2026-10-15
00840828197182MBA-WE,P37,INL,1',DPCURBELL MEDICAL PRODUCTS, INC.FNL2026-10-15
00840828197199MBA-WE,P37,INL,6',DPCURBELL MEDICAL PRODUCTS, INC.FNL2026-10-15
00840828197205MBA-WE,P37(90),1',DPCURBELL MEDICAL PRODUCTS, INC.FNL2026-10-15
00840828197212MBA-WE,P37(90),6',DPCURBELL MEDICAL PRODUCTS, INC.FNL2026-10-15
06979878770374CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-10-06
06972077023883CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024125CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024132CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024149CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024156CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024163CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024316CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024323CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025030CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025047CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025054CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025061CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025078CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025085CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06975084500675AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06975084500682AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06975084500699AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
00841447197966INVACARE® DLX SERIES BED RAILINVACARE CORPORATIONFNL2026-09-22
00841447198048INVACARE® THINKSOFT® POSITIONING DEVICEINVACARE CORPORATIONFNL2026-09-22
06972077025191CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500071SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19