FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50887488896388
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-5538B
Catalog number
34-5538B
Device description
STERILE INJECTION TRAY
Published
2018-01-11
Public version status
Update
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
OFQAnesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488896388PackageGS125In Commercial Distribution
10887488896380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748889638850887488896388
1088748889638010887488896380

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various sterile 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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956540408CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-25
10198956569508CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-25
10198956580343CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-25
10198956581470CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-25
10198956569324CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
10198956572560CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
10198956573444CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
10198956577091CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
10198956465510CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956535558CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956538344CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956538818CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956554610CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956564138CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956549616CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-26
10198956547360CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-18
10198956551442CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-18
10198956394773CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-17
10198956533066CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-17
10198956461734CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956511798CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956524651CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956530706CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956531024CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956531031CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956435728CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-20
10198956524613CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-20
10198956518650CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-16
10198956437500CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-09
10198956202320CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-06