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DJO Global DVT Sleeve

FDA UDI

Class II (US FDA UDI)

by Renu Medical, Inc

Identity

Trade Name
DJO Global DVT Sleeve FDA UDI
Generic Name
Multi-chamber venous compression system garment, reprocessed FDA UDI
Device Name
Aircast VenaFlow Elite Calf Cuff FDA UDI
Model / Reference
RM-3040 FDA UDI
Description
Aircast VenaFlow Elite Calf Cuff FDA UDI

Identifiers

Primary DI / UDI-DI
00816317020019 FDA UDI
510(k) Number
K121145 FDA UDI
FDA Product Code
JOW FDA UDI
GMDN Term
Multi-chamber venous compression system garment, reprocessed FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multi-chamber venous compression system garment, reprocessed

DJO Global DVT Sleeve by Renu Medical, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-chamber venous compression system garment, reprocessed.

Cleared under the same submission

K121145 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Renu Medical, Inc

Sources (1)

  • FDA UDI 4b2d98e5-1435-4e73-8e36-b6b7da296bab 34 fields · synced May 30, 2026