FDA.report

IsoAir

Primary DI
00841965100677
Brand
IsoAir
Company
Tridien Medical
Model
2940
Catalog number
12SM-SALV-KIT
Device description
Controller Kit,120/60Hz,SAUD,SR
Published
2017-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841965100677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841965100677008419651006778419651006770841965100677

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
1 800 474 4225info@tridien.com

Regulatory Flags

DUNS number
625060962
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 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
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
00841965100769IsoAir294012SM-SRLVC-BH2017-01-13

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