Blue Boot

FDA UDI

Class II (US FDA UDI)

by Normatec Industries, Lp

Identity

Trade Name: Blue Boot FDA UDI
Generic Name: Intermittent venous compression system FDA UDI
Device Name: 4 Cell Custom Blue Boot (OS 1-29) FDA UDI
Model / Reference: 4 Cell Boot FDA UDI
Description: 4 Cell Custom Blue Boot (OS 1-29) FDA UDI

Identifiers

Catalog Number: 20104 FDA UDI
Primary DI / UDI-DI: 00817369020286 FDA UDI
510(k) Number: K013436 FDA UDI
K112890 FDA UDI
FDA Product Code: JOW FDA UDI
IRP FDA UDI
GMDN Term: Intermittent venous compression system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5800 FDA UDI
890.5650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Intermittent venous compression system Sequential venous compression system

Blue Boot by Normatec Industries, Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Sequential venous compression system.

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AeroWrap™ Flex Large — SUN-SCIENTIFIC INC. · Class I
Rapid Reboot Recovery Products — RAPID REBOOT RECOVERY PRODUCTS · Class II
CoreTech — VIVE HEALTH LLC · Class II
AeroWrap™ — SUN-SCIENTIFIC INC. · Class I
Compression Therapy Device — Guangzhou Longest Medical Technology Co., Ltd. · Class II
Aero-Wrap™ Bilateral Kit, Medium — SUN-SCIENTIFIC INC. · Class I

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Normatec Industries, Lp

Sources (1)

FDA UDI f3905f52-9f38-487e-89e0-e935aab0c794 35 fields · synced May 30, 2026