FDA.reportPublic FDA data

CompreFLEX

Primary DI
00745129312060
Brand
CompreFLEX
Company
SIGVARIS INC
Model
24KP
Catalog number
2413-KP
Device 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.
Published
2024-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDRBinder, Medical, Therapeutic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDRBinder, Medical, TherapeuticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00745129312060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129312060007451293120607451293120600745129312060

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose medical foam padding, single-useA roll, sheet or preformed shape of synthetic latex foam material [e.g., styrene-butadiene rubber (SBR)] intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)322-7744sigvariscares@sigvaris.com

Regulatory Flags#

DUNS number
189738719
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613378196171862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Black3206013206012026-03-19
07613378196188862N-CUSTOM ECF2 AG Quadrinova UNI °° Black3206003206002026-03-19
07613378196577862N-CUSTOM ECF2 AG Quadrinova UNI Black3205613205612026-03-19
07613378196959862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Caramel3205233205232026-03-19
07613378196966862N-CUSTOM ECF2 AG Quadrinova UNI °° Caramel3205223205222026-03-19
07613378197352862N-CUSTOM ECF2 AG Quadrinova UNI Caramel3204833204832026-03-19
07613378197734862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Grey3204453204452026-03-19
07613378197741862N-CUSTOM ECF2 AG Quadrinova UNI °° Grey3204443204442026-03-19
07613378198137862N-CUSTOM ECF2 AG Quadrinova UNI Grey3204053204052026-03-19
07613378198519862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Savanna3203673203672026-03-19
07613378198526862N-CUSTOM ECF2 AG Quadrinova UNI °° Savanna3203663203662026-03-19
07613378198915862N-CUSTOM ECF2 AG Quadrinova UNI Savanna3203273203272026-03-19
07613378199301862N-CUSTOM ECF2 AG Quadrinova UNI °° Skin3202883202882026-03-19
07613378199691862N-CUSTOM ECF2 AG Quadrinova UNI Skin3202493202492026-03-19
07613378277122862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Grey3554563554562026-03-19
07613378277139862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Caramel3554573554572026-03-19
07613378277146862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Skin3554583554582026-03-19
07613378277153862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Savanna3554593554592026-03-19
07613378277177862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Marine3554613554612026-03-19
07613378277184862N-CUSTOM ECF2 AG Micro knobbed band UNI Grey3554623554622026-03-19

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Primary DI, Brand, Company table
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