ThermoTek WRAP, DVT, CALF SET, PUSH, SPU

Basic Information

• Brand Name: ThermoTek WRAP, DVT, CALF SET, PUSH, SPU
• Primary DI: 00850033615272
• Version / Model: 0P9BNDVTCA4
• Catalog Number: 0P9BNDVTCA4
• Company Name: THERMOTEK, INC.
• Labeler DUNS: 847899911
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-21
• Public Version: 1
• Public Version Date: 2026-03-02
• Public Version Status: New
• Public Device Record Key: d0db47d8-32b2-4c31-ae1b-4433b918e78d

Device Description

WRAP, DVT, CALF SET, PUSH, SPU

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOW	Sleeve, Limb, Compressible	Cardiovascular	870.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44769	Single-chamber venous compression system garment, single-use	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850033615272	GS1

Premarket Submissions

Submission Number	Supplement Number
K061866	000