FDA.reportPublic FDA data

Stratus Pump 7.1 (220 V)

Primary DI
00845699001903
Brand
Stratus Pump 7.1 (220 V)
Company
SIZEWISE RENTALS, L.L.C.
Model
8741172
Published
2019-02-06
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
00845699001903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845699001903008456990019038456990019030845699001903

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure pumpA mains electricity (AC-powered) device that forces ambient air into the parallel chambers of an alternating-pressure bed mattress overlay or an alternating-pressure chair cushion, for the timed alternation of chamber inflation and thereby exchange of patient contact points. The pump, which may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient.

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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