FDA.report

CARDINAL HEALTH

Primary DI
50197106866496
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN24ENOX4
Catalog number
SEN24ENOX4
Device description
ENT PACK
Published
2024-12-11
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
OAAAid, visual, for nausea

Product Code Classifications

CodeDeviceSpecialtyClass
OAAAid, Visual, For NauseaUnknownN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106866496PackageGS14In Commercial Distribution
10197106866498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019710686649650197106866496
1019710686649810197106866498

GMDN Terms

TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. 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
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50198956219043CARDINAL HEALTHSBA29BRCCFSBA29BRCCF2026-03-24
50198956219401CARDINAL HEALTHSOT29UR87ESOT29UR87E2026-03-24
50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
50198956220643CARDINAL HEALTHSCV29MN87ESCV29MN87E2026-03-24
50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
50198956284980CARDINAL HEALTH34-8041H34-8041H2026-03-24
50198956285987CARDINAL HEALTHSBACNLSMBGSBACNLSMBG2026-03-24
50198956300116CARDINAL HEALTH17C4553C17C4553C2026-03-24
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
50198956101843CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956102093CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956110203CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956101294CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
50198956101416CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
50197106908790CARDINAL HEALTHCardinal Health 200, LLCOAA2025-01-02
50197106824441CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
50197106835348CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
50197106825158CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-06
50197106852246CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
50197106859023CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
50197106810246CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-25
50197106721047CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-15
50197106796106CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-13
50197106828104CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-13
50197106832613CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-13
50197106769612CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-07
50197106826797CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-07
50197106697175CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-06
50197106789672CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-06
50197106752881CARDINAL HEALTHCardinal Health 200, LLCOAA2024-10-22
50197106764051CARDINAL HEALTHCardinal Health 200, LLCOAA2024-10-22
50197106805976CARDINAL HEALTHCardinal Health 200, LLCOAA2024-10-16
50197106756476CARDINAL HEALTHCardinal Health 200, LLCOAA2024-10-15
50197106800131CARDINAL HEALTHCardinal Health 200, LLCOAA2024-10-11
50197106756988CARDINAL HEALTHCardinal Health 200, LLCOAA2024-10-07
50197106748518CARDINAL HEALTHCardinal Health 200, LLCOAA2024-09-25
50197106742219CARDINAL HEALTHCardinal Health 200, LLCOAA2024-09-18
50197106743278CARDINAL HEALTHCardinal Health 200, LLCOAA2024-09-12
50197106744107CARDINAL HEALTHCardinal Health 200, LLCOAA2024-09-11