FDA.reportPublic FDA data

5904 Bandage Kit

Primary DI
00745129313906
Brand
5904 Bandage Kit
Company
SIGVARIS INC
Model
5904
Catalog number
5904-BK
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
00745129313906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129313906007451293139067451293139060745129313906

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
07613378196157862W-CUSTOM ECF2 AGT WaistAttachment UNI °° Black3206033206032026-05-18
07613378196164862T-CUSTOM ECF2 AG SoftTop UNI °° Black3206023206022026-05-18
07613378196553862T-CUSTOM ECF2 AG SoftTop UNI Black3205633205632026-05-18
07613378196560862N-CUSTOM ECF2 AG SensinovaUnisex UNI Black3205623205622026-05-18
07613378196942862T-CUSTOM ECF2 AG SoftTop UNI °° Caramel3205243205242026-05-18
07613378197338862T-CUSTOM ECF2 AG SoftTop UNI Caramel3204853204852026-05-18
07613378197345862N-CUSTOM ECF2 AG SensinovaUnisex UNI Caramel3204843204842026-05-18
07613378197727862T-CUSTOM ECF2 AG SoftTop UNI °° Grey3204463204462026-05-18
07613378198113862T-CUSTOM ECF2 AG SoftTop UNI Grey3204073204072026-05-18
07613378198120862N-CUSTOM ECF2 AG SensinovaUnisex UNI Grey3204063204062026-05-18
07613378198502862T-CUSTOM ECF2 AG SoftTop UNI °° Savanna3203683203682026-05-18
07613378198892862T-CUSTOM ECF2 AG SoftTop UNI Savanna3203293203292026-05-18
07613378198908862N-CUSTOM ECF2 AG SensinovaUnisex UNI Savanna3203283203282026-05-18
07613378199288862T-CUSTOM ECF2 AG SoftTop UNI °° Skin3202903202902026-05-18
07613378199677862T-CUSTOM ECF2 AG SoftTop UNI Skin3202513202512026-05-18
07613378199684862N-CUSTOM ECF2 AG SensinovaUnisex UNI Skin3202503202502026-05-18
07613378277504862N-CUSTOM ECF2 AG SensinovaUnisex UNI marine3555233555232026-05-18
07613378277511862T-CUSTOM ECF2 AG SoftTop UNI marine3555243555242026-05-18
07613378277900862T-CUSTOM ECF2 AG SoftTop UNI °° marine3555633555632026-05-18
00745129334581422C Motion Thermo Wool 20-30mmHG U LL Denim MSTRP422CLL39 or 22061422CLL392026-05-11

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