Dover

Primary DI
50192253028124
Brand
Dover
Company
Cardinal Health 200, LLC
Model
6156
Catalog number
6156-
Device description
HYDROGEL COATED LATEX FOLEY TRAY, 18 FR (6.0 MM), 5 CC, 2000 ML DRAINAGE BAG, DRAIN SPOUT
Published
2024-12-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PPGUrinary drainage collection kit

Product Code Classifications

CodeDeviceSpecialtyClass
PPGUrinary Drainage Collection KitGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253028124PackageGS110In Commercial Distribution
10192253028126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225302812450192253028124
1019225302812610192253028126

GMDN Terms

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.

Device Sizes

TypeValueUnit
Catheter Gauge18French
Total Volume2000Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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