FDA.reportPublic FDA data

Stryker Air

Primary DI
00841965103210
Brand
Stryker Air
Company
Tridien Medical
Model
2861
Catalog number
60SM-5006
Device description
HV,Intl,AfterMarket,Contrl, AR
Published
2017-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IOQBed, Flotation Therapy, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOQBed, Flotation Therapy, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841965103210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841965103210008419651032108419651032100841965103210

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
1 800 474 4225info@tridien.com

Regulatory Flags#

DUNS number
625060962
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841965100486IsoAir294045A-SR5-35842017-01-13
00841965100493IsoAir294045A-SR5-32802017-01-13
00841965100509IsoAir294045A-SR5-35802017-01-13
00841965100516IsoAir294045A-SR8-32802017-01-13
00841965100523IsoAir294045A-SR8-35802017-01-13
00841965100554SenTechAir Chair77-SM22BAC-B2017-01-27
00841965100592Stryker Air286160SM-20002017-01-13
00841965100608IsoAir294012SM-SRLV-BH2017-01-13
00841965100615IsoAir294012SM-USLV-KIT2017-01-13
00841965100622IsoAir2940SYS-SR-0022017-01-13
00841965100653SenTechSentry 125012-SM50-R2016-09-19
00841965100660IsoAir294012SM-EUHV-KIT2017-01-13
00841965100677IsoAir294012SM-SALV-KIT2017-01-13
00841965100684Stryker Air286160SM-30002017-01-13
00841965100691IsoAir294012SM-SRHV-E2017-01-13
00841965100707Stryker Air286260SM-40002017-01-13
00841965100714IsoAir294012SM-SRHV-G2017-01-13
00841965100721Stryker Air286260SM-40012017-01-13
00841965100745IsoAir294012SM-SRHV-I2017-01-13
00841965100752IsoAir294012SM-SRHV-J2017-01-13

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