FDA.reportPublic FDA data

12 MedaFit

Primary DI
00745129306793
Brand
12 MedaFit
Company
SIGVARIS INC
Model
12BK
Catalog number
1204-BKS-R
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
2024-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00745129306793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129306793007451293067937451293067930745129306793

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00745129335120Envelo Arm Wrap Medium Short Beige3112-ARS or 221153112-ARS2026-07-22
00745129335137Envelo Arm Wrap Medium Regular Beige3112-ARR or 221163112-ARR2026-07-22
00745129335144Envelo Arm Wrap Medium Long Beige3112-ARL or 221173112-ARL2026-07-22
00745129335151Envelo Arm Wrap Max Medium Short Beige3112-AMS or 221183112-AMS2026-07-22
00745129335168Envelo Arm Wrap Max Medium Regular Beige3112-AMR or 221193112-AMR2026-07-22
00745129335175Envelo Arm Wrap Max Medium Long Beige3112-AML or 221203112-AML2026-07-22
00745129335182Envelo Arm Wrap Large Short Beige3113-ARS or 221213113-ARS2026-07-22
07613378196126862P-CUSTOM ECF2 AT1L SoftTop FEM °° Black3206063206062026-07-22
07613378196522862P-CUSTOM ECF2 AT SoftTop MEN Black3205663205662026-07-22
07613378196911862P-CUSTOM ECF2 AT SoftTop MEN °° Caramel3205273205272026-07-22
07613378197307862P-CUSTOM ECF2 AT SoftTop MEN Caramel3204883204882026-07-22
07613378197697862P-CUSTOM ECF2 AT SoftTop MEN °° Grey3204493204492026-07-22
07613378198083862P-CUSTOM ECF2 AT SoftTop MEN Grey3204103204102026-07-22
07613378198472862P-CUSTOM ECF2 AT SoftTop MEN °° Savanna3203713203712026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00745129334963Envelo Arm Wrap X-Large Long BlackSIGVARIS INCMDR2026-07-20
00745129334970Envelo Arm Wrap Max X-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129334987Envelo Arm Wrap Max X-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129334994Envelo Arm Wrap Max X-Large Long BlackSIGVARIS INCMDR2026-07-20
00745129335007Envelo Arm Wrap XX-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129335014Envelo Arm Wrap XX-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129335021Envelo Arm Wrap XX-Large Long BlackSIGVARIS INCMDR2026-07-20
00745129335038Envelo Arm Wrap Max XX-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129335045Envelo Arm Wrap Max XX-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129335052Envelo Arm Wrap Max XX-Large Long BlackSIGVARIS INCMDR2026-07-20
08300496073246SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15
08300496073253SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15