FDA.report

Flexitouch

Primary DI
00816305020175
Brand
Flexitouch
Company
TACTILE SYSTEMS TECHNOLOGY, INC.
Model
L-FL-LO-L
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications

CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816305020175PrimaryGS10

GMDN Terms

TermDefinition
Multi-chamber venous compression system garment, reusableAn inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
146295980
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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00816305025071NimblDS PL-HL-00-LR2025-07-17
00816305024838NimblPL-FL-SH-L703329-0012025-02-28
00816305024845NimblPL-FL-SH-R703329-0022025-02-28
00816305024852NimblPL-FL-LO-L703327-0012025-02-28
00816305024869NimblPL-FL-LO-R703327-0022025-02-28
00816305024876NimblPD08-N1703434-0022025-02-28
00816305024944Nimbl704515-001N/A2025-02-28
00816305024951Nimbl704515-002N/A2025-02-28
00816305024968Nimbl704514-001N/A2025-02-28
00816305024975NimblPL-HL-00-LR704179-0012025-02-28
00816305024982NimblPL-EX-SH-LR704004-0012025-02-28
00816305024999NimblPL-EX-LO-LR704005-0012025-02-28
00816305025002NimblR PD08-N1703434-0032025-02-28
00816305024883nimbl704237-001N/A2025-01-23
00816305024647nimblPL-AR-SH-LR2024-08-05
00816305024654nimblPL-AR-LO-LR2024-08-05
00816305024661nimblPD08-N1703438-0012024-08-05

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