FDA.report

CARDINAL HEALTH

Primary DI
50887488564393
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
13-0134D
Catalog number
13-0134D
Device description
STERILE SINGLE SHOT CAUDAL PK
Published
2016-07-28
Public version status
Update
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
OGBCaudal anesthesia kit

Product Code Classifications

CodeDeviceSpecialtyClass
OGBCaudal Anesthesia KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50887488564393PackageGS120In Commercial Distribution
10887488564395PrimaryGS10

GMDN Terms

TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. 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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50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
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50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
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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

Primary DIBrandCompanyProduct codePublished
50887488873938CARDINAL HEALTHCardinal Health 200, LLCOGB2017-12-01
50887488790723CARDINAL HEALTHCardinal Health 200, LLCOGB2017-09-12
50887488517559CARDINAL HEALTHCardinal Health 200, LLCOGB2016-08-03
50885425321269CARDINAL HEALTHCardinal Health 200, LLCOGB2016-07-18
50887488441762CARDINAL HEALTHCardinal Health 200, LLCOGB2016-07-15