FDA.report

SelectAir Max

Primary DI
00817365021089
Brand
SelectAir Max
Company
MOXI ENTERPRISES, LLC
Model
SAMAXSYSK010SP
Device description
SELECT AIR MAX MATTRESS REPL SYSTEM NON-FOOTED W/SELECT PROTECT
Published
2016-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817365021089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817365021089008173650210898173650210890817365021089

GMDN Terms

TermDefinition
Low-air-loss bedA mains electricity (AC-powered) bed that permits a controlled release of air through its dedicated mattress and is used for tissue pressure management during patient confinement in a hospital acute care department and nursing homes. The device consists of a mattress made of a series of connected air inflated pillows upon which the patient lies, a compressor with a feed system, filters and a built-in control unit.

Sterilization Methods

Method

Regulatory Flags

DUNS number
958807575
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
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

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00817365021706SelectAirFC-MXHYUS5FC-MXHYUS52023-03-29
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00817365021836SelectAirPM-SACV398008PM-SACV3980082022-11-04
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00817365021867SelectAirSA39NOFTCOVSA39NOFTCOV2022-11-04
00817365021874SelectAirSA42COV-NHT SA42COV-NHT 2022-11-04
00817365021898SelectAirSA42NOFTCOVSA42NOFTCOV2022-11-04
00817365021904SelectAirSA48COV-NHT SA48COV-NHT 2022-11-04
00817365021911SelectAirSA48NOFTCOVSA48NOFTCOV2022-11-04
00817365021928SelectAirSA54COV-NHT SA54COV-NHT 2022-11-04
00817365021935SelectAirSA54NOFTCOVSA54NOFTCOV2022-11-04
00817365021942SelectAirSA60COV-NHT SA60COV-NHT 2022-11-04
00817365021959SelectAirSA60NOFTCOVSA60NOFTCOV2022-11-04

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