FDA.reportPublic FDA data

5253 Bandages and Supplies

Primary DI
00745129304379
Brand
5253 Bandages and Supplies
Company
SIGVARIS INC
Model
5253
Catalog number
5253
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
2024-01-22
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
FMPProtector, Skin Pressure
FQMBandage, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00745129304379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129304379007451293043797451293043790745129304379

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze roll/sheetA device in the form of a long length of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. 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
00089904011459Action®ACTION PRODUCTS, INC.FMP2026-07-23
00089904011435Action®ACTION PRODUCTS, INC.FMP2026-07-21
00089904011442Action®ACTION PRODUCTS, INC.FMP2026-07-21
00609271999336Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999343Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999374Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999381Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999473Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999480Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00089904011428Action®ACTION PRODUCTS, INC.FMP2026-07-17
00850088144024CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144031CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144048CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144055CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144062CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144079CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144086CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144666CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00850088144673CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00850088144680CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00089904011411Action®ACTION PRODUCTS, INC.FMP2026-07-06
00816299013337HoverMatt PROSWedgeHovertech InternationalFMP2026-07-06
00089904011404Action®ACTION PRODUCTS, INC.FMP2026-06-08
00850087488273CeeportCEEPORT INC.FQM2026-06-08
00505627930841Repose Flex Large x10 &Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308434Repose Flex Large x1 & Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308458Repose Flex Large x10 &Pump x10Frontier Therapeutics IncFMP2026-06-05
06978479041074LotfancyAnhui Medsport Medical Products Co., Ltd.FQM2026-06-03
00860010482674AcanthusAcanthus Medical Creations LLCFMP2026-05-27
08809302580645New Soosung Elastic Bandagesoosung medicalFQM2025-12-26