FDA.report

CARDINAL HEALTH

Primary DI
20192253022602
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SU130-1525
Catalog number
SU130-1525
Device description
JP PERF DRN PVC RND 19FR CTR
Published
2020-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GBXCATHETER, IRRIGATION

Product Code Classifications

CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20192253022602PackageGS110In Commercial Distribution
50192253022603PackageGS18In Commercial Distribution
10192253022605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225302260220192253022602
5019225302260350192253022603
1019225302260510192253022605

GMDN Terms

TermDefinition
Closed-wound drain, non-bioabsorbableA tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
961027315
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
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