FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380043260
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
C4330-5
Catalog number
C4330-5
Device description
xylene 5gal
Published
2026-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KEMAGENT, CLEARING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEMAgent, ClearingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380043268PrimaryGS10
10885380043260Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538004326850885380043268
1088538004326010885380043260

GMDN Terms#

Term, Definition table
TermDefinition
Xylene solution IVDA xylene solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333066021829EliA Stool Extraction Buffer plusPhadia ABKEM2026-06-25
50885380043268CARDINAL HEALTHCardinal Health 200, LLCKEM2026-01-06
00613647028438FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
00613647028506FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
00613647028513FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
00613647028636FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
20613647028432FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
20613647028500FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
20613647028517FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
20613647028630FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
00673693086974EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693087032EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693088923EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693101561EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693101592EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693101608EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693228374EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693236102EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693236133EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693236140EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693476126EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693556736EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693755078EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693755085EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693755115EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693087025EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-22
00673693476133EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-22
00810047420583N/AScientific Device Laboratory, Inc.KEM2023-01-31
00810047420989N/AScientific Device Laboratory, Inc.KEM2023-01-31
00810047420996N/AScientific Device Laboratory, Inc.KEM2023-01-31