FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956102217
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PL21DEBR5
Catalog number
PL21DEBR5
Device description
KIT, BRISTOL DELIVERY
Published
2025-06-05
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
MLADNA PROBE, YEAST

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLADna Probe, YeastMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956102215PackageGS11In Commercial Distribution
10198956102217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895610221550198956102215
1019895610221710198956102217

GMDN Terms#

Term, Definition table
TermDefinition
Birthing/delivery kitA collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. This is a single-use device.

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
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
50198956102215CARDINAL HEALTHCardinal Health 200, LLCMLA2025-06-05
10197106086612CARDINAL HEALTHCardinal Health 200, LLCMLA2022-12-15
10195594702809CARDINAL HEALTHCardinal Health 200, LLCMLA2022-05-31
50195594702807CARDINAL HEALTHCardinal Health 200, LLCMLA2022-05-31
10195594572495CARDINAL HEALTHCardinal Health 200, LLCMLA2022-02-21
50195594572493CARDINAL HEALTHCardinal Health 200, LLCMLA2022-02-21
00382904462529BD Affirm™ VPIII Microbial Identification TestBECTON, DICKINSON AND COMPANYMLA2018-05-25
00382904462574BD Affirm™ VPIII Microbial Identification TestBECTON, DICKINSON AND COMPANYMLA2018-05-25