DirectVision

Primary DI
10855308006042
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
OTC
false
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 kitA collection of sterile devices that includes an indwelling urethral catheter (commonly known as a Foley catheter), gloves, lubricating gel, and other related accessories intended for the drainage of urine from the bladder. The catheter has an inflatable balloon at the distal tip for retention in the urinary bladder after its insertion through the urethra, where it usually functions as an indwelling therapeutic device for urinary incontinence or as a means to void for non-ambulatory patients. The catheter will be applied by trained staff and may or may not be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015755434
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855308006007DirectVisionMA1002822016-09-23
00855308006014DirectVisionMA1001802016-09-23
00855308006045DirectVisionMA1001432016-09-23
10855308006004DirectVisionMA1002822016-09-23
10855308006011DirectVisionMA1001802016-09-23
00855308006021DirectVisionMA1002882016-09-23
00855308006038DirectVisionMA1000592016-09-23