FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594572495
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
ORO8108612
Catalog number
ORO8108612
Device description
KIT,OB DLVRY, BERGAN MERCY,6 C
Published
2022-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
50195594572493PackageGS16In Commercial Distribution
10195594572495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559457249350195594572493
1019559457249510195594572495

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
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
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
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