FDA.reportPublic FDA data

CompreFLEX

Primary DI
00745129313395
Brand
CompreFLEX
Company
SIGVARIS INC
Model
MS01
Catalog number
MSC1401LINER
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
2024-01-23
Public version status
Update
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
00745129313395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129313395007451293133957451293133950745129313395

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose medical foam padding, single-useA roll, sheet or preformed shape of synthetic 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

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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00745129313197CompreFLEXMS01MSC14012024-01-23
00745129313203CompreFLEXMS02MSC14022024-01-23
00745129313210CompreFLEXMS03MSC14032024-01-23
00745129313227CompreFLEXMS04MSC14042024-01-23
00745129313234CompreFLEXMS05MSC14052024-01-23
00745129313241CompreFLEXMS01MSC1401T2024-01-23
00745129313258CompreFLEXMS02MSC1402T2024-01-23
00745129313265CompreFLEXMS03MSC1403T2024-01-23
00745129313272CompreFLEXMS04MSC1404T2024-01-23
00745129313289CompreFLEXMS05MSC1405T2024-01-23
00745129313401CompreFLEXMS02MSC1402LINER2024-01-23
00745129313418CompreFLEXMS03MSC1403LINER2024-01-23
00745129313425CompreFLEXMS04MSC1404LINER2024-01-23
00745129313432CompreFLEXMS05MSC1405LINER2024-01-23
00745129335069Envelo Arm Wrap Small Short Beige3111-ARS or 221093111-ARS2026-07-22
00745129335076Envelo Arm Wrap Small Regular Beige3111-ARR or 221103111-ARR2026-07-22
00745129335083Envelo Arm Wrap Small Long Beige3111-ARL or 221113111-ARL2026-07-22
00745129335090Envelo Arm Wrap Max Small Short Beige3111-AMS or 221123111-AMS2026-07-22
00745129335106Envelo Arm Wrap Max Small Regular Beige3111-AMR or 221133111-AMR2026-07-22
00745129335113Envelo Arm Wrap Max Small Long Beige3111-AML or 221143111-AML2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08300496073765SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073772SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073789SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073796SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073802SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073819SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073826SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073833SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073840SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073857SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073864SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
08300496073871SOLIDEACALZIFICIO PINELLI SRLMDR2026-10-16
00745129335069Envelo Arm Wrap Small Short BeigeSIGVARIS INCMDR2026-07-22
00745129335076Envelo Arm Wrap Small Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335083Envelo Arm Wrap Small Long BeigeSIGVARIS INCMDR2026-07-22
00745129335090Envelo Arm Wrap Max Small Short BeigeSIGVARIS INCMDR2026-07-22
00745129335106Envelo Arm Wrap Max Small Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335113Envelo Arm Wrap Max Small Long BeigeSIGVARIS INCMDR2026-07-22
00745129335120Envelo Arm Wrap Medium Short BeigeSIGVARIS INCMDR2026-07-22
00745129335137Envelo Arm Wrap Medium Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335144Envelo Arm Wrap Medium Long BeigeSIGVARIS INCMDR2026-07-22
00745129335151Envelo Arm Wrap Max Medium Short BeigeSIGVARIS INCMDR2026-07-22
00745129335168Envelo Arm Wrap Max Medium Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335175Envelo Arm Wrap Max Medium Long BeigeSIGVARIS INCMDR2026-07-22
00745129335182Envelo Arm Wrap Large Short BeigeSIGVARIS INCMDR2026-07-22
00745129334918Envelo Arm Wrap Max Large Short BlackSIGVARIS INCMDR2026-07-20
00745129334925Envelo Arm Wrap Max Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129334932Envelo Arm Wrap Max Large Long BlackSIGVARIS INCMDR2026-07-20
00745129334949Envelo Arm Wrap X-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129334956Envelo Arm Wrap X-Large Regular BlackSIGVARIS INCMDR2026-07-20