FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594406408
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN54IRMT4
Catalog number
SAN54IRMT4
Device description
IR PACK MOUNTAIN VISTA
Published
2021-10-25
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
OIORadiographic contrast tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIORadiographic Contrast TrayRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594406408PackageGS13In Commercial Distribution
10195594406400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559440640850195594406408
1019559440640010195594406400

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
10198956474239CARDINAL HEALTHCardinal Health 200, LLCOIO2026-05-25
50198956401714CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-24
50198956327496CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-23
50198956337334CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-23
50198956360271CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-23
50198956384949CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-23
50198956409611CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-23
50198956417586CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-23
50198956362107CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-19
50198956413304CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-19
50198956412338CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-16
50198956426595CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-16
50198956400076CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-10
50198956416893CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-10
50198956344844CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-06
50198956333947CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-02
50198956346152CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-02
50198956354157CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-02
50198956357813CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-02
50198956383683CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-02
50198956386820CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-02
50198956390032CARDINAL HEALTHCardinal Health 200, LLCOIO2026-03-02
50198956335620CARDINAL HEALTHCardinal Health 200, LLCOIO2026-02-23
50198956349221CARDINAL HEALTHCardinal Health 200, LLCOIO2026-02-23
50198956373479CARDINAL HEALTHCardinal Health 200, LLCOIO2026-02-23
50198956346305CARDINAL HEALTHCardinal Health 200, LLCOIO2026-02-20
50198956368925CARDINAL HEALTHCardinal Health 200, LLCOIO2026-02-20
50198956316551CARDINAL HEALTHCardinal Health 200, LLCOIO2026-02-17
50198956360523CARDINAL HEALTHCardinal Health 200, LLCOIO2026-02-13
50198956318173CARDINAL HEALTHCardinal Health 200, LLCOIO2026-02-09