FDA.report

CARDINAL HEALTH

Primary DI
50195594750488
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA35LDM11
Catalog number
SMA35LDM11
Device description
L AND D PERI GYN
Published
2022-07-07
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

Related Records

Product Codes

CodeName
MLSLabor and Delivery Kit

Product Code Classifications

CodeDeviceSpecialtyClass
MLSLabor And Delivery KitObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594750488PackageGS12In Commercial Distribution
10195594750480PrimaryGS10

GMDN Terms

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

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 DIBrandModelCatalogPublished
50198956219043CARDINAL HEALTHSBA29BRCCFSBA29BRCCF2026-03-24
50198956219401CARDINAL HEALTHSOT29UR87ESOT29UR87E2026-03-24
50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
50198956220643CARDINAL HEALTHSCV29MN87ESCV29MN87E2026-03-24
50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
50198956284980CARDINAL HEALTH34-8041H34-8041H2026-03-24
50198956285987CARDINAL HEALTHSBACNLSMBGSBACNLSMBG2026-03-24
50198956300116CARDINAL HEALTH17C4553C17C4553C2026-03-24
50198956300499CARDINAL HEALTHSAN12BSSUJSAN12BSSUJ2026-03-24
50198956302929CARDINAL HEALTHSOP32SHFLKSOP32SHFLK2026-03-24
50198956306866CARDINAL HEALTHSBAOCBLCPCSBAOCBLCPC2026-03-24
50198956307986CARDINAL HEALTHSOP21EPSCGSOP21EPSCG2026-03-24
50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956420531CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-24
50198956421040CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-24
50198956417753CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956419818CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956420548CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956420760CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956427820CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-23
50198956310092CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956393774CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956407365CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956408805CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956413946CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-19
50198956318609CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956401363CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956414950CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956418774CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-16
50198956278064CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956313925CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956408706CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956408959CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411416CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411485CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956411775CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-10
50198956366099CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-09
50198956396492CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-09
50198956403916CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-09
50198956365641CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-06
50198956402605CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-06
50198956404630CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-06
50198956403466CARDINAL HEALTHCardinal Health 200, LLCMLS2026-03-03