FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106530399
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEY3WEYJA8
Catalog number
SEY3WEYJA8
Device description
EYE PACK
Published
2024-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJKEye tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106530397PackageGS112In Commercial Distribution
10197106530399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710653039750197106530397
1019710653039910197106530399

GMDN Terms#

Term, Definition table
TermDefinition
Hygiene apron, single-useA non-sterile garment designed to be worn by healthcare staff for general protection from soiling or spills on the ventral (front) aspect of the body, and typically to prevent penetration of infectious material, during the course of work or a procedure. It is typically made of a thin plastic polymer. This is a single-use garment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956227552CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956418899CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956475380CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956475441CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956475489CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956477551CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956489264CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956498556CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956501911CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-08
10198956470507CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956490260CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956491960CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956492776CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956493001CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956493377CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956495173CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956496569CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956499744CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-05
10198956397682CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956417229CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956478992CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10198956487642CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-03
10197106817643CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956351738CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956407084CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956410145CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956418387CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956421219CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956421257CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01
10198956439559CARDINAL HEALTHCardinal Health 200, LLCOJK2026-06-01