FDA.report

CARDINAL HEALTH

Primary DI
50197106577972
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
01-2655A
Catalog number
01-2655A
Device description
IV START KIT
Published
2024-04-19
Public version status
New
Distribution status
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
LAAHigh pressure liquid chromatography, benzodiazepine

Product Code Classifications

CodeDeviceSpecialtyClass
LAAHigh Pressure Liquid Chromatography, BenzodiazepineClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106577972PackageGS172In Commercial Distribution
10197106577974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019710657797250197106577972
1019710657797410197106577974

GMDN Terms

TermDefinition
Peripheral intravenous catheterization support kitA collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device.

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
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

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50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
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50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

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