FDA.report

CARDINAL HEALTH

Primary DI
50195594955715
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SVA12PLFSA
Catalog number
SVA12PLFSA
Device description
PHLEBECTOMY PACK
Published
2021-03-31
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
50195594955715PackageGS14In Commercial Distribution
10195594955717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559495571550195594955715
1019559495571710195594955717

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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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50198956219401CARDINAL HEALTHSOT29UR87ESOT29UR87E2026-03-24
50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
50198956220643CARDINAL HEALTHSCV29MN87ESCV29MN87E2026-03-24
50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
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50198956285987CARDINAL HEALTHSBACNLSMBGSBACNLSMBG2026-03-24
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50198956300499CARDINAL HEALTHSAN12BSSUJSAN12BSSUJ2026-03-24
50198956302929CARDINAL HEALTHSOP32SHFLKSOP32SHFLK2026-03-24
50198956306866CARDINAL HEALTHSBAOCBLCPCSBAOCBLCPC2026-03-24
50198956307986CARDINAL HEALTHSOP21EPSCGSOP21EPSCG2026-03-24
50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

Other Devices Sharing Product Codes

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20809160466602Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-05-08
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00860009842274Straight Needle Phlebotomy KitLabcorp Genetics IncOFM2025-02-13
00860009842281Butterfly Needle Phlebotomy KitLabcorp Genetics IncOFM2025-02-13
20809160432508Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-08-16
20809160424428Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-04-30
20194717117824Regard™ROI CPS, LLCOFM2023-09-29
20194717117831Regard™ROI CPS, LLCOFM2023-09-29
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00852714003187Aurix XLNuo Therapeutics, Inc.OFM2023-03-27
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50195594971517CARDINAL HEALTHCardinal Health 200, LLCOFM2021-04-07
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20809160342036Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2021-01-06
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