FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106816392
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN11LGUH6
Catalog number
SEN11LGUH6
Device description
LARYNGOSCOPY PACK
Published
2024-10-31
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

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
50197106816392PackageGS14In Commercial Distribution
10197106816394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710681639250197106816392
1019710681639410197106816394

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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956377196CARDINAL HEALTHCardinal Health 200, LLCOGH2026-03-31
10198956330627CARDINAL HEALTHCardinal Health 200, LLCOGH2026-02-09
50198956330625CARDINAL HEALTHCardinal Health 200, LLCOGH2026-02-09
05707480163205Ambu® SureSight® Mobile Mini KitAmbu A/SOGH2025-12-19
05707480163267Ambu® SureSight® Mobile KitAmbu A/SOGH2025-12-19
05707480163212Ambu® SureSight® Mobile Mini KitAmbu A/SOGH2025-12-19
05707480163274Ambu® SureSight® Mobile KitAmbu A/SOGH2025-12-19
10197106816394CARDINAL HEALTHCardinal Health 200, LLCOGH2024-10-31
10197106728970CARDINAL HEALTHCardinal Health 200, LLCOGH2024-08-21
50197106728978CARDINAL HEALTHCardinal Health 200, LLCOGH2024-08-21
10197106314395CARDINAL HEALTHCardinal Health 200, LLCOGH2023-11-14
50197106314393CARDINAL HEALTHCardinal Health 200, LLCOGH2023-11-14
10197106409015CARDINAL HEALTHCardinal Health 200, LLCOGH2023-08-31
50197106409013CARDINAL HEALTHCardinal Health 200, LLCOGH2023-08-31
00191072194480ACSAMERICAN CONTRACT SYSTEMS, INC.OGH2023-05-01
00810094575588CuraplexBOUND TREE MEDICAL, LLCOGH2023-03-30
00612649181264Video laryngoscope aBlade kitKing Systems CorporationOGH2022-12-08
00612649178073King Vision Video Laryngoscope KitKing Systems CorporationOGH2022-12-08
00612649182100Video laryngoscope aBlade kitKing Systems CorporationOGH2022-12-08
10195594579692CARDINAL HEALTHCardinal Health 200, LLCOGH2022-05-06
50195594579690CARDINAL HEALTHCardinal Health 200, LLCOGH2022-05-06
10195594552435CARDINAL HEALTHCardinal Health 200, LLCOGH2022-03-23
50195594552433CARDINAL HEALTHCardinal Health 200, LLCOGH2022-03-23
10195594544676CARDINAL HEALTHCardinal Health 200, LLCOGH2022-02-26
50195594544674CARDINAL HEALTHCardinal Health 200, LLCOGH2022-02-26
10888439932447CARDINAL HEALTHCardinal Health 200, LLCOGH2021-10-07
50888439932445CARDINAL HEALTHCardinal Health 200, LLCOGH2021-10-07
10195594321871CARDINAL HEALTHCardinal Health 200, LLCOGH2021-09-16
50195594321879CARDINAL HEALTHCardinal Health 200, LLCOGH2021-09-16
10195594296575CARDINAL HEALTHCardinal Health 200, LLCOGH2021-09-07