FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594321879
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN11LGUH5
Catalog number
SEN11LGUH5
Device description
LARYNGOSCOPY PACK
Published
2021-09-16
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
50195594321879PackageGS14In Commercial Distribution
10195594321871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559432187950195594321879
1019559432187110195594321871

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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

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
50197106816392CARDINAL 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
10195594296575CARDINAL HEALTHCardinal Health 200, LLCOGH2021-09-07