FDA.report

CARDINAL HEALTH

Primary DI
50195594969729
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SVA15PHFHA
Catalog number
SVA15PHFHA
Device description
PHLEBECTOMY PACK
Published
2021-04-07
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
OFMPhlebotomy blood collection kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFMPhlebotomy Blood Collection KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594969729PackageGS13In Commercial Distribution
10195594969721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559496972950195594969729
1019559496972110195594969721

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.

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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50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

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20809160432508Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-08-16
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