FDA.report

Flexitouch

Primary DI
00816305020106
Brand
Flexitouch
Company
TACTILE SYSTEMS TECHNOLOGY, INC.
Model
PD32-U
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
00816305020106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816305020106008163050201068163050201060816305020106

GMDN Terms

TermDefinition
Intermittent venous compression system pumpAn electrically-powered device used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit with the necessary pressure to promote venous blood flow. This is achieved through the cyclical inflation and deflation of a single-chambered stocking/sleeve/suit applied to the extremities. It typically consists of a compressor with control/timing mechanism, pressure limiting device, tubing, and connectors. 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.

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
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
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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