FDA.reportPublic FDA data

TRANSRADIAL PRESSURE BANDAGE

Primary DI
00850004162255
Brand
TRANSRADIAL PRESSURE BANDAGE
Company
VALFLUX GROUP, LLC
Model
VGPB04B
Catalog number
VGPB04B
Device description
VGPB04B TRANSRADIAL PRESSURE BANDAGE
Published
2018-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAXTOURNIQUET, NONPNEUMATIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004162255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004162255008500041622558500041622550850004162255

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, non-sterile, single-useA non-sterile strip or roll of fabric or plastic material (non-latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+556230916442regulacao@valflux.com.br

Regulatory Flags#

DUNS number
050193715
Device count
1
Premarket exempt
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850004162217SELDINGER NEEDLEVGSN03VGSN032018-12-19
00850004162224SELDINGER NEEDLEVGSN03AVGSN03A2018-12-19
00850004162231SELDINGER NEEDLEVGSN06VGSN062018-12-19
00850004162125INTRODUCER SETVGCTR03VGCTR032018-12-20
00850004162132INTRODUCER SETVGCTR03AVGCTR03A2018-12-20
00850004162149INTRODUCER SETVGCTR04VGCTR042018-12-20
00850004162156INTRODUCER SETVGCTR04AVGCTR04A2018-12-20
00850004162163INTRODUCER SETVGHIS00VGHIS002018-12-20
00850004162170INTRODUCER SETVGHIS01VGHIS012018-12-20
00850004162187INTRODUCER SETVGHIS02VGHIS022018-12-20
00850004162194INTRODUCER SETVGHIS03VGHIS032018-12-20
00850004162200INTRODUCER SETVGHIS04VGHIS042018-12-20
00850004162248TRANSRADIAL PRESSURE BANDAGEVGPB04AVGPB04A2018-12-19
00850004162019MANIFOLDVGAM0201VGAM02012018-12-19
00850004162026MANIFOLDVGAM0301VGAM03012018-12-19
00850004162033MANIFOLDVGAM0401VGAM04012018-12-19
00850004162040INFLATION DEVICEVGAI25CVGAI25C2018-12-19
00850004162057Y CONNECTOR KITVGYCK113FVGYCK113F2018-12-19
00850004162064HIGH PRESSURE TUBINGVGPMT0501VGPMT05012018-12-18
00850004162071HIGH PRESSURE TUBINGVGPMT0502VGPMT05022018-12-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20665973032393DukalDukal LLCGAX2025-04-08
20665973032409DukalDukal LLCGAX2025-04-08
20197344105363MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
30197344006230MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
00087453143478HysynalHYGENIC CORPORATION, THEGAX2025-03-10
30382903671992BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903672050BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903671985BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
30382903672098BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
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