FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20192253003830
Brand
CARDINAL HEALTH
Company
CARDINAL HEALTH 200, LLC
Model
42110PG
Catalog number
42110PG
Device description
ISOLATION GOWN UNIVERSAL POLY-COATED SPUNBOND BLUE OVER THE HEAD THUMBLOOP LATEX FREE NONSTERILE HALF BACK
Published
2019-05-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
QPCGown, non-sterile, non-isolation, intended to provide moderate or high barrier protection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier ProtectionGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253003831PackageGS15Not in Commercial Distribution
20192253003830PrimaryGS10
10192253003833Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225300383150192253003831
2019225300383020192253003830
1019225300383310192253003833

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Regulatory Flags#

DUNS number
112164780
Device count
6
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50192253071595CONVERTORS8184NA8184NA2026-06-02
50192253071601CONVERTORS8187N8187N2026-06-02
50192253071618CONVERTORS8188NC8188NC2026-06-02
50192253071625CONVERTORS8189N8189N2026-06-02
20192253005971CONVERTORSAT7004AT70042019-04-16
20192253017080Kendall31.3876.0431.3876.042023-03-16
50885380183001CARDINAL HEALTH50001218500012182023-08-11
50885380182998CARDINAL HEALTH50001217500012172023-08-11
10197106817643CARDINAL HEALTHSEYHBDPANBSEYHBDPANB2026-06-01
10198956004887CARDINAL HEALTHSBAHFRPASCSBAHFRPASC2026-06-01
10198956201804CARDINAL HEALTH32-0828C32-0828C2026-06-01
10198956209220CARDINAL HEALTHPG33GLVWBPG33GLVWB2026-06-01
10198956225992CARDINAL HEALTHSOP54PPUOBSOP54PPUOB2026-06-01
10198956245754CARDINAL HEALTHSBACGKTACFSBACGKTACF2026-06-01
10198956248908CARDINAL HEALTHSAN43CATOBSAN43CATOB2026-06-01
10198956269323CARDINAL HEALTHSOP4QSHCLBSOP4QSHCLB2026-06-01
10198956311282CARDINAL HEALTHSCV11VSJKJSCV11VSJKJ2026-06-01
10198956312043CARDINAL HEALTHPW30PSPRHPW30PSPRH2026-06-01
10198956314634CARDINAL HEALTHSBAMIFPACBSBAMIFPACB2026-06-01
10198956314894CARDINAL HEALTHSEN42HNAMDSEN42HNAMD2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10326053121491Regard™Resource Optimization & Innovation, L.L.C.QPC2024-11-28
10326053121507Regard™Resource Optimization & Innovation, L.L.C.QPC2024-11-28
10326053121514Regard™Resource Optimization & Innovation, L.L.C.QPC2024-11-28
20326053121498Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.QPC2024-11-28
20326053121504Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.QPC2024-11-28
20326053121511Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.QPC2024-11-28
10197344036301MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-09-02
20197344036308MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-09-02
10197344036318MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-08-13
10197344036325MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-08-13
30197344036312MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-08-13
30197344036329MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-08-13
00612899045484EncompassEncompass Group, L.L.C.QPC2023-06-22
00612899101104EncompassEncompass Group, L.L.C.QPC2023-06-22
20860005250039ProtectXThe Azac GroupQPC2022-04-07
20860005250060ProtectXThe Azac GroupQPC2022-04-07
20192253003816CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
20192253003823CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
20192253003847CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
20192253003854CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
50192253003817CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
50192253003824CARDINAL HEALTHCARDINAL HEALTH 200, LLCQPC2019-05-10
50192253003831CARDINAL HEALTHCARDINAL HEALTH 200, LLCQPC2019-05-10
50192253003848CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10
50192253003855CARDINAL HEALTHCardinal Health 200, LLCQPC2019-05-10