FDA.reportPublic FDA data

ARTEK PRO-01 WRAP

Primary DI
00850033615050
Brand
ARTEK PRO-01 WRAP
Company
THERMOTEK, INC.
Model
0P9BATPUNVWRC01
Catalog number
0P9BATPUNVWRC01
Device description
WRAP, ARTEK PRO-01, UNV COMP01
Published
2023-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850033615050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850033615050008500336150508500336150500850033615050

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid thermal/compression therapy system wrapA non-sterile component of a circulating-fluid thermal/compression therapy system intended to facilitate, through thermal therapy (heating and/or cooling) and compression, the treatment of a variety of adverse conditions resulting from a musculoskeletal injury/orthopaedic surgery (e.g., pain, swelling, inflammation). It is intended to be fastened around a single or multiple anatomies and consists of: a heat exchanger, which enables heated and/or cooled fluid from the system control unit to be circulated; and an external sleeve, which enables intermittent compression via inflation. It is intended for use in both professional and home settings. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9728744949slee@thermotekusa.com

Regulatory Flags#

DUNS number
847899911
Device count
1
Lot or batch
true
Manufacturing date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976287180367Compression Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.JOW2026-07-10
00672736141649BREGBREG, INC.JOW2026-06-25
04719893351026WellellWellell Inc.JOW2026-03-17
06973641887146CRYOPUSHChengdu Cryo-push Medical Technology Co.,Ltd.ILO2026-03-12
08809802648494DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802648500DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802646810DVT-2600DAESUNG MAREF CO.,LTD.JOW2025-12-19
08809802646858DVT-4000SDAESUNG MAREF CO.,LTD.JOW2025-12-19
10080196138302MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-14
06973641888518CryoRxChengdu Cryo-push Medical Technology Co.,Ltd.ILO2025-09-16
10192253057775CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057782CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057799CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057805CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057812CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057829CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10193489003154MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-04-17
10193489003161MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-21
10080196391974MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-18
10192253057768CARDINAL HEALTHCardinal Health 200, LLCJOW2025-02-19
10080196385409MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-01-02
10192253016123Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016130Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016185Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253057737CARDINAL HEALTHCardinal Health 200, LLCJOW2024-10-02
10885380184895CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184901CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184918CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184925CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
08809802644458DVT-PRODAESUNG MAREF CO.,LTD.JOW2023-12-11