FDA.reportPublic FDA data

Flexitouch

Primary DI
00816305021226
Brand
Flexitouch
Company
Tactile Systems Technology, Inc.
Model
PD32-120
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816305021226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816305021226008163050212268163050212260816305021226

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
146295980
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816305025088FlexiTouch Plus704705-001N/A2025-08-11
00816305025095Nimbl703439-001N/A2025-08-11
00816305025064FlexiTouch Plus702610-0012025-07-17
00816305025071NimblDS PL-HL-00-LR2025-07-17
00816305023596Airwear Air Compression WrapAW-SM-01-BK2019-10-18
00816305023602Airwear Air Compression WrapAW-MD-01-BK2019-10-18
00816305023619Airwear Air Compression WrapAW-LG-01-BK2019-10-18
00816305023626Airwear Air Compression WrapAW-XL-01-BK2019-10-18
00816305023633Airwear Air Compression WrapAW-SO-01-WH2019-10-18
00816305023640Airwear Air Compression WrapAW-PU-01-GR2019-10-18
00816305020731ACTitouch500222-1002016-09-20
00816305020748ACTitouch500222-100-002016-09-20
00816305020755ACTitouch500222-2002016-09-20
00816305020762ACTitouch500222-200-002016-09-20
00816305020779ACTitouch500222-3002016-09-20
00816305020786ACTitouch500222-300-002016-09-20
00816305020793ACTitouch500222-4002016-09-20
00816305020809ACTitouch500222-400-002016-09-20
00816305020816ACTitouch500222-5002016-09-20
00816305020823ACTitouch500222-500-002016-09-20

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Primary DI, Brand, Company table
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08809802646858DVT-4000SDAESUNG MAREF CO.,LTD.JOW2025-12-19
10080196138302MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-14
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10192253016185Kendall SCDCardinal Health 200, LLCJOW2024-12-16
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10197106500439CARDINAL HEALTHCardinal Health 200, LLCJOW2023-12-28