FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956330625
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN4FLYWFC
Catalog number
SEN4FLYWFC
Device description
LARYNGOSCOPY SCOPE
Published
2026-02-09
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

Product Codes#

Code, Name table
CodeName
OGHLaryngoscope kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGHLaryngoscope KitAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956330625PackageGS16In Commercial Distribution
10198956330627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895633062550198956330625
1019895633062710198956330627

GMDN Terms#

Term, Definition table
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 table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05707480163212Ambu® SureSight® Mobile Mini KitAmbu A/SOGH2025-12-19
05707480163274Ambu® SureSight® Mobile KitAmbu A/SOGH2025-12-19
50197106816392CARDINAL HEALTHCardinal Health 200, LLCOGH2024-10-31
50197106728978CARDINAL HEALTHCardinal Health 200, LLCOGH2024-08-21
50197106314393CARDINAL HEALTHCardinal Health 200, LLCOGH2023-11-14
50197106409013CARDINAL HEALTHCardinal Health 200, LLCOGH2023-08-31
00191072194480ACSAMERICAN CONTRACT SYSTEMS, INC.OGH2023-05-01
00810094575588CuraplexBOUND TREE MEDICAL, LLCOGH2023-03-30
00612649178073King Vision Video Laryngoscope KitKing Systems CorporationOGH2022-12-08
00612649182100Video laryngoscope aBlade kitKing Systems CorporationOGH2022-12-08
50195594579690CARDINAL HEALTHCardinal Health 200, LLCOGH2022-05-06
50195594552433CARDINAL HEALTHCardinal Health 200, LLCOGH2022-03-23
50195594544674CARDINAL HEALTHCardinal Health 200, LLCOGH2022-02-26
50888439932445CARDINAL HEALTHCardinal Health 200, LLCOGH2021-10-07
50195594321879CARDINAL HEALTHCardinal Health 200, LLCOGH2021-09-16
50195594296573CARDINAL HEALTHCardinal Health 200, LLCOGH2021-09-07
50195594257239CARDINAL HEALTHCardinal Health 200, LLCOGH2021-07-30
50195594230331CARDINAL HEALTHCardinal Health 200, LLCOGH2021-07-19
50195594169624CARDINAL HEALTHCardinal Health 200, LLCOGH2021-07-02
50195594097705CARDINAL HEALTHCardinal Health 200, LLCOGH2021-05-25
50195594093318CARDINAL HEALTHCardinal Health 200, LLCOGH2021-05-18
50195594046970CARDINAL HEALTHCardinal Health 200, LLCOGH2021-04-27
50195594907165CARDINAL HEALTHCardinal Health 200, LLCOGH2021-01-21
50888439963487CARDINAL HEALTHCardinal Health 200, LLCOGH2020-12-14
00191072116864ACSAMERICAN CONTRACT SYSTEMS, INC.OGH2020-09-24
00191072094711ACSAMERICAN CONTRACT SYSTEMS, INC.OGH2020-09-03
00191072039637ACSAMERICAN CONTRACT SYSTEMS, INC.OGH2020-06-24
50888439752968CARDINAL HEALTHCardinal Health 200, LLCOGH2020-03-04
50888439588178CARDINAL HEALTHCardinal Health 200, LLCOGH2019-10-31
50888439607909CARDINAL HEALTHCardinal Health 200, LLCOGH2019-10-22