Black Boot

FDA UDI

Class II (US FDA UDI)

by Normatec Industries, Lp

Identity

Trade Name: Black Boot FDA UDI
Generic Name: Intermittent venous compression system FDA UDI
Device Name: Standard Zippered Boot Black FDA UDI
Model / Reference: Standard Zippered Boot Black FDA UDI
Description: Standard Zippered Boot Black FDA UDI

Identifiers

Catalog Number: 20008 FDA UDI
Primary DI / UDI-DI: 00817369020187 FDA UDI
FDA Product Code: IRP FDA UDI
JOW FDA UDI
GMDN Term: Intermittent venous compression system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5650 FDA UDI
870.5800 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

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

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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 3ce27bb2-fe94-4505-b62d-1a22ffd0691e 34 fields · synced Jun 8, 2026