CARDINAL HEALTH

Primary DI
50810010890998
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
FO2
Catalog number
FO2
Device description
Foil Pouch; Printed White
Published
2019-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OIBBlood and urine collection kit (excludes HIV testing)

Product Code Classifications

CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50810010890998PackageGS1100In Commercial Distribution
10810010890990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5081001089099850810010890998
1081001089099010810010890990

GMDN Terms

TermDefinition
Phlebotomy kitA collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.

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
false
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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