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14 CompreFLEX Transition

FDA UDI

Class I (US FDA UDI)

by Sigvaris, Inc.

Identity

Trade Name
14 CompreFLEX Transition FDA UDI
Generic Name
General-purpose medical foam padding, single-use FDA UDI
Device Name
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device. FDA UDI
Model / Reference
14UC FDA UDI
Description
Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device. FDA UDI

Identifiers

Catalog Number
1414-UC-BKR FDA UDI
Primary DI / UDI-DI
00745129305093 FDA UDI
FDA Product Code
MDR FDA UDI
GMDN Term
General-purpose medical foam padding, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5160 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose medical fibre paddingGeneral-purpose medical foam padding, single-use

14 CompreFLEX Transition by Sigvaris, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose medical foam padding, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sigvaris, Inc.

Sources (1)

  • FDA UDI 8af26475-0204-4828-ac1f-22f697878618 36 fields · synced May 29, 2026