FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20192253003847
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
4211PG
Catalog number
4211PG
Device description
GOWN POLYCOATED THMBHKS UNIV BLUE
Published
2019-05-10
Public version status
Update
Distribution status
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
50192253003848PackageGS110In Commercial Distribution
20192253003847PrimaryGS10
10192253003840Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225300384850192253003848
2019225300384720192253003847
1019225300384010192253003840

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
961027315
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

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
20192253003830CARDINAL 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