FDA.reportPublic FDA data

Platinum 6000 54

Primary DI
00845699001132
Brand
Platinum 6000 54
Company
SIZEWISE RENTALS, L.L.C.
Model
PLAT5480
Published
2019-02-01
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
FMRDevice, Transfer, Patient, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845699001132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845699001132008456990011328456990011320845699001132

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress systemAn assembly of devices consisting of an alternating-pressure bed mattress (inflation-patterned air cells with or without foam component) and a dedicated electric 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.

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845699002412SizewiseBT39862024-09-20
00845699002429SizewiseBT48862024-09-20
00845699002436SizewiseMA39862024-09-20
00845699002443SizewiseMA48862024-09-20
00845699002450SizewiseBPUL 39862024-09-20
00845699002474SizewiseNP126 39802024-09-20
00845699002481SizewiseNP126 42802024-09-20
00845699002498SizewiseNP12G 3948802024-09-20
00845699002504SizewiseNPT3 G 39802024-09-20
00845699002511SizewiseNPT3 G 42802024-09-20
00845699002528SizewiseNPT3 G 48802024-09-20
00845699002535SizewiseNPT3 G 3948802024-09-20
00845699002597SizewiseENVY NPT335882024-09-20
00845699002603SizewiseENVY NP935882024-09-20
00845699002610SizewiseADP 35882024-09-20
00845699002627SizewiseADP PLAT35882024-09-20
00845699002634SizewiseADP LAL35882024-09-20
00845699002641SizewiseADP PULLAL35882024-09-20
00845699002658SizewiseADP ROLAL35882024-09-20
00845699002672SizewiseIMLAL 35802024-09-20

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Primary DI, Brand, Company table
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05059441537298AIRPALArjohuntleigh ABFMR2026-03-23
05059441537304AIRPALArjohuntleigh ABFMR2026-03-23
05059441537311AIRPALArjohuntleigh ABFMR2026-03-23
05059441537328AIRPALArjohuntleigh ABFMR2026-03-23
05059441537335AIRPALArjohuntleigh ABFMR2026-03-23
05059441537342AIRPALArjohuntleigh ABFMR2026-03-23
00850056748360APLS Thermal WrapINTEGRATED MEDCRAFT LLCFMR2026-02-16
07333350703745Tortoise™ Turning & positioning systemMölnlycke Health Care ABFMR2026-02-11
07333350636012Tortoise™ Turning & positioning systemMölnlycke Health Care ABFMR2026-02-11
07613327681710N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.FMR2026-02-11
06975575170103YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-02-10
06975575170028YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170035YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170042YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170059YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
06975575170097YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FMR2026-01-30
00199284069657Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00199284569546Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00199284790896Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970710Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970727Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970734Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970741Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970758Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970765Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970772Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860006970796Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860015268808Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00860015268815Med SledEthos Evacuation Strategies, LLCFMR2026-01-27
00850056748292FORWARD APLS Litter GuardINTEGRATED MEDCRAFT LLCFMR2026-01-15