FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20192253003823
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
4203PG
Catalog number
4203PG
Device description
ISOLATION GOWN XL POLY-COATED SPUNBOND BLUE OVER THE HEAD KNIT CUFF LATEX FREE NONSTERILE HALF BACK
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
50192253003824PackageGS110In Commercial Distribution
20192253003823PrimaryGS10
10192253003826Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225300382450192253003824
2019225300382320192253003823
1019225300382610192253003826

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

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
20192253003830CARDINAL 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