FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106471609
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
MAT4397442
Catalog number
MAT4397442
Device description
KIT,MATERNITY
Published
2023-10-05
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
PAAAutomated breast ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAAAutomated Breast UltrasoundUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106471607PackageGS18In Commercial Distribution
10197106471609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710647160750197106471607
1019710647160910197106471609

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. 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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278756138InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2025-03-12
00195278756237InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2025-03-04
10197106527344CARDINAL HEALTHCardinal Health 200, LLCPAA2024-02-02
50197106527342CARDINAL HEALTHCardinal Health 200, LLCPAA2024-02-02
10197106530061CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-21
50197106530069CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-21
10197106493168CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-14
50197106493166CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-14
50197106471607CARDINAL HEALTHCardinal Health 200, LLCPAA2023-10-05
10197106038543CARDINAL HEALTHCardinal Health 200, LLCPAA2023-06-05
50197106038541CARDINAL HEALTHCardinal Health 200, LLCPAA2023-06-05
10197106192573CARDINAL HEALTHCardinal Health 200, LLCPAA2023-03-30
50197106192571CARDINAL HEALTHCardinal Health 200, LLCPAA2023-03-30
00860000221306SoftVueDelphinus Medical Technologies, IncPAA2022-12-07
10195594787271CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-12
50195594787279CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-12
10195594783907CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-10
50195594783905CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-10
00840682141161InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2018-09-04
10885425282814CARDINAL HEALTHCARDINAL HEALTH 200, LLCPAA2016-07-27
50885425282812CARDINAL HEALTHCardinal Health 200, LLCPAA2016-07-27
00840682100090InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2016-01-29
00840682100014InveniaGE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLCPAA2014-09-24
00840682100021InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2014-09-24
00840682100038InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2014-09-24