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Covidien DVT Sleeve

FDA UDI

Class II (US FDA UDI)

by Renu Medical, Inc

Identity

Trade Name
Covidien DVT Sleeve FDA UDI
Generic Name
Multi-chamber venous compression system garment, reprocessed FDA UDI
Device Name
Kendall SCD Express Thigh Small FDA UDI
Model / Reference
RM-9545 FDA UDI
Description
Kendall SCD Express Thigh Small FDA UDI

Identifiers

Primary DI / UDI-DI
00816317022914 FDA UDI
510(k) Number
K031559 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

Covidien 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

K031559 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 2b94795e-e6b3-49db-b92c-4932f9b9d505 34 fields · synced May 30, 2026