FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106409013
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SENMHGOBH3
Catalog number
SENMHGOBH3
Device description
LARYNGOSCOPY PACK
Published
2023-08-31
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
50197106409013PackageGS18In Commercial Distribution
10197106409015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710640901350197106409013
1019710640901510197106409015

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

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
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