FDA.report

5405 Bandages and Supplies

Primary DI
00745129304461
Brand
5405 Bandages and Supplies
Company
SIGVARIS INC
Model
5405
Catalog number
5405
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FQMBandage, Elastic

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00745129304461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129304461007451293044617451293044610745129304461

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810178881192Dr PatsVIVE HEALTH LLCFQM2026-02-05
00810178881208Dr PatsVIVE HEALTH LLCFQM2026-02-05
00810178884599ViveCareVIVE HEALTH LLCFQM2026-02-05
00810178884605ViveCareVIVE HEALTH LLCFQM2026-02-05
00810178884612ViveCareVIVE HEALTH LLCFQM2026-02-05
08809302580652New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580683New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580928New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580874New Soosung Elastic Bandagesoosung medicalFQM2025-12-24
08809302587538Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587545Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587552Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587569Soosung Elastic Bandagesoosung medicalFQM2025-12-11
00029369186019McDavidDoctor Shock IncFQM2025-12-01
00029369186026McDavidDoctor Shock IncFQM2025-12-01
26975803530802GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530819GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530826GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530833GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530840GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530857GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530864GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
16975803530874GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
30840330705869ProCureTwin Med, LLCFQM2025-11-26
30840330705876ProCureTwin Med, LLCFQM2025-11-26
30840330705883ProCureTwin Med, LLCFQM2025-11-26
04250381827123Head bandageSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
04250381827130Head bandageSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
04250381827147Elastic head bandage with ear slipSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
50192253065280CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15