Flexitouch

Primary DI
00816305021479
Brand
Flexitouch
Company
TACTILE SYSTEMS TECHNOLOGY, INC.
Model
DS U-AR-SH-R
Published
2017-05-05
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

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
00816305021479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816305021479008163050214798163050214790816305021479

GMDN Terms#

Term, Definition table
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 table
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#

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
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850033615494ThermoTek WRAP,DVT,CA,SET,PUSH,SPU, QTY 10, CTNTHERMOTEK, INC.JOW2026-02-21
00812311022479Bio Arterial DeluxeBio Compression Systems, IncJOW2026-02-13
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10816317024427Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
10816317024434Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
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