FDA.reportPublic FDA data

SPECIALTY

Primary DI
06975084500071
Brand
SPECIALTY
Company
XIAMEN ATLANTIS MFC CO.,LTD
Model
SPFPRIMAIR80
Published
2026-09-19
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
06975084500071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975084500071069750845000716975084500071

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress overlay systemAn assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

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
06972077023128CostcareL300C2026-09-19
06972077025191CostcareBC3372026-09-19
06972077025399MeditecL5152026-09-19
06975084500088DALTONML400-0022026-09-19
06975084500095CostcareML400-0012026-09-19
06975084500415SPECIALTYSPFPRIMAIR80RS2026-09-19
06975084500422SPECIALTYSPFPRIMAIR842026-09-19
06975084500439SPECIALTYSPFPRIMAIR42802026-09-19
06975084500446SPECIALTYSPFPRIMAIR4280RS2026-09-19
06975084500453SPECIALTYSPFPRIMAIR80-CVR2026-09-19
06975084500460SPECIALTYSPFPRIMAIR80RS-CVR2026-09-19
06975084500477SPECIALTYSPFPRIMAIR84-CVR2026-09-19
06975084500484SPECIALTYSPFPRIMAIR4280-CVR2026-09-19
06975084500491SPECIALTYSPFPRIMAIR4280RS-CVR2026-09-19
06975084500507SPECIALTYSPFPRIMAIR-EQCN2026-09-19
06975084500514SPECIALTYSPFPRIMAIR-PMP2026-09-19
06975084500521SPECIALTYSPFPRIMAIR42842026-09-19
06975084500538SPECIALTYSPFPRIMAIR4284-CVR2026-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972077025191CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500088DALTONXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500095CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500415SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500422SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500439SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500446SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500453SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500460SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500477SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500484SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500491SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500507SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500514SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500521SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500538SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06979878770312CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770329CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770336CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770343CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770350CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770367CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
008408281968570103,SCC,10',RAULAND LABELED,UL,PVC-FREECURBELL MEDICAL PRODUCTS, INC.FNL2026-07-23
08592654620359Eleganza 5L I N E T spol. s r.o.FNL2026-07-17
08592654621752Eleganza 5L I N E T spol. s r.o.FNL2026-07-17
04719876190055TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190277TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190574TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190581TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190598TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08