FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439909203
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA35VGPL4
Catalog number
SMA35VGPL4
Device description
VAG DELIVERY PK
Published
2020-09-25
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
MLSLabor and Delivery Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLSLabor And Delivery KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439909201PackageGS16In Commercial Distribution
10888439909203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843990920150888439909201
1088843990920310888439909203

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
10192253004489SharpSafety85221852212026-09-24
10192253004502Monoject8522Y8522Y2026-09-24
10192253004557Monoject8533Y8533Y2026-09-24
10192253004571Monoject8536SA8536SA2026-09-24
10192253004632SharpSafety8541SA8541SA2026-09-24
10192253005059Monoject89651896512026-09-24
10192253005080Monoject8967Y8967Y2026-09-24
10192253005493Monoject8506Y8506Y2026-09-24
20885380075169CARDINAL HEALTHUSA-N95-SUSA-N95-S2016-08-02
20885380075183CARDINAL HEALTHUSA-N95-RUSA-N95-R2016-08-02
10198956271418CARDINAL HEALTHSMADKCSOGDSMADKCSOGD2026-09-22
10198956273979CARDINAL HEALTHSNE41APFMASNE41APFMA2026-09-22
10198956313897CARDINAL HEALTHSNE69CRWHESNE69CRWHE2026-09-22
10198956320598CARDINAL HEALTH28-1807Z28-1807Z2026-09-22
10198956333758CARDINAL HEALTHSMA73GLKCHSMA73GLKCH2026-09-22
10198956336667CARDINAL HEALTHSBA57PIOHQSBA57PIOHQ2026-09-22
10198956338661CARDINAL HEALTH08-8060I08-8060I2026-09-22
10198956339255CARDINAL HEALTHSAN23CCPRFSAN23CCPRF2026-09-22
10198956346222CARDINAL HEALTHSMAHDRLAGBSMAHDRLAGB2026-09-22
10198956350434CARDINAL HEALTHPE23THMEHPE23THMEH2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956543638CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956555372CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956563742CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956579675CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-22
10198956504158CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956571648CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956571891CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956572966CARDINAL HEALTHCardinal Health 200, LLCMLS2026-09-04
10198956549685CARDINAL HEALTHCardinal Health 200, LLCMLS2026-08-18
10198956555167CARDINAL HEALTHCardinal Health 200, LLCMLS2026-08-17
10198956541337CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-31
10809160527894HalyardAVID MEDICAL, INC.MLS2026-07-28
10809160527900HalyardAVID MEDICAL, INC.MLS2026-07-28
10198956412262CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956467903CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956483996CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956495883CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956511453CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956514065CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956527935CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956534766CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956535312CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956536289CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956537026CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-27
10198956461154CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956463721CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956514768CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956531376CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956532861CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-20
10198956501935CARDINAL HEALTHCardinal Health 200, LLCMLS2026-07-16