FDA.reportPublic FDA data

ThermoTek WRAP,DVT,CA,SET,PUSH,SPU, QTY 10, CTN

Primary DI
00850033615494
Brand
ThermoTek WRAP,DVT,CA,SET,PUSH,SPU, QTY 10, CTN
Company
THERMOTEK, INC.
Model
0P9BNDVTCA4-CTN
Catalog number
0P9BNDVTCA4-CTN
Device description
WRAP,DVT,CA,SET,PUSH,SPU, QTY 10, CTN
Published
2026-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061866000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061866000NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPSThermotek, Inc.2006-08-22JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033615494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033615494008500336154948500336154940850033615494

GMDN Terms#

Term, Definition table
TermDefinition
Single-chamber venous compression system garment, single-useAn inflatable device in the form of a stocking, sleeve, or suit intended to be 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 intermittent inflation of a single-chamber. 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
847899911
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033615227Echo Ultrasound Device (PRC) 0V52XX1001JK01-CTN0V52XX1001JK01-CTN2026-02-23
00850033615258Echo Ultrasound Device (PRC)0V52XX1001JK010V52XX1001JK012026-02-23
00850033615289Echo Ultrasound Device (USA)0V52XX1002JK01-CTN0V52XX1002JK01-CTN2026-02-23
00850033615340Echo Ultrasound Device (USA)0V52XX1002JK010V52XX1002JK012026-02-23
00850033615371Echo BOX, DRESSING & GEL POD PACK, USND, PRC0V52XX1003JK01 0V52XX1003JK01 2026-02-23
00850033615388Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXES0V52XX1003JK01-CTN0V52XX1003JK01-CTN2026-02-23
00850033615425Echo Ultra Sound Gel Pods, Carton0V52XX1004JK01-CTN0V52XX1004JK01-CTN2026-02-23
00850033615487Echo Ultra Sound Gel Pod, Single0V52XX1004JK010V52XX1004JK012026-02-23
00850033615500Echo APPLICATOR, SINGLE, USND0V52XX1005JK010V52XX1005JK012026-02-23
00850033615517Echo POWER SUPPLY, CORD, SINGLE, USND0V52XX1006JK010V52XX1006JK012026-02-23
00850033615531Echo BELT CLIP, DEVICE PRTCTR, SNGL,USND0V52XX1007JK010V52XX1007JK012026-02-23
00850033615555Echo ARM STRAP, DEVICE PRTCTR, SNG, USND0V52XX1008JK010V52XX1008JK012026-02-23
00850033615562Echo GEL, TUBE, SINGLE, USND0V52XX1009JK010V52XX1009JK012026-02-23
00850033615586echoRx, MANUAL, USER, SINGLE, USND0V52XX1010JK010V52XX1010JK012026-02-23
00850033615593echoRx, GUIDE,QUICK START,SNGL,USND0V52XX1011JK010V52XX1011JK012026-02-23
00850033615616ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UF0P9BCFKNMR3EXT-U 0P9BCFKNMR3EXT-U 2026-02-23
00850033615623Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXES0V52XX1012JK01-CTN 0V52XX1012JK01-CTN 2026-02-23
00850033615630Echo BOX, DRESSING & GEL POD PACK, USND, USA0V52XX1012JK010V52XX1012JK012026-02-23
00850033615647THERAPY SYSTEM, ARTEK PRO-020P9PTATP020P9PTATP022026-02-23
00850033615081ThermoTek WRAP, BACK W/BRACE,LSO,ONE-SIZE0P9BLSBXBK0P9BLSBXBK2026-02-21

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