DirectVision

Primary DI
00855308006045
Brand
DirectVision
Company
PERCUVISION LLC
Model
MA100143
Device description
DirectVision Catheterization Kit
Published
2016-09-23
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855308006042PackageGS110In Commercial Distribution
00855308006045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085530800604210855308006042
00855308006045008553080060458553080060450855308006045

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kit, adultA collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Regulatory Flags#

DUNS number
015755434
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855308006007DirectVisionMA1002822016-09-23
00855308006014DirectVisionMA1001802016-09-23
10855308006004DirectVisionMA1002822016-09-23
10855308006011DirectVisionMA1001802016-09-23
00855308006021DirectVisionMA1002882016-09-23
00855308006038DirectVisionMA1000592016-09-23
10855308006042DirectVisionMA1001432016-09-23