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
10884521022683Monoject85121851212016-09-24
10884521023437Monoject890689062019-07-19
30884521018444Monoject8990Y8990Y2017-01-06
40884521018298Monoject89671896712016-09-24
40884521018380Monoject8970Y8970Y2017-01-06
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23

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