FDA.report

TheraFlo P.U. US Tridien

Primary DI
00841965103753
Brand
TheraFlo P.U. US Tridien
Company
Tridien Medical
Model
S2001-3101
Catalog number
2001002
Device description
TheraFlo P.U. US Tridien
Published
2016-09-19
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
IOQBed, Flotation Therapy, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IOQBed, Flotation Therapy, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841965103753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841965103753008419651037538419651037530841965103753

GMDN Terms

TermDefinition
Alternating-pressure bed mattress overlay, reusableA pad or thin mattress, usually full-body length, which is placed on top of a bed mattress and designed with parallel chambers that are alternately filled with forced-air to actively change an 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. This is a reusable device.

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
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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00841965100653SenTechSentry 125012-SM50-R2016-09-19
00841965100660IsoAir294012SM-EUHV-KIT2017-01-13
00841965100677IsoAir294012SM-SALV-KIT2017-01-13
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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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