FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956102215
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
OTC
false
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.

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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956102217CARDINAL 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