FDA.report

CARDINAL HEALTH

Primary DI
50192253020128
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
7300PG
Catalog number
7300PG
Device description
GOWN ISO POLYCOATED KNTCUFF UNV WHT
Published
2019-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OEANon-surgical isolation gown

Product Code Classifications

CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253020128PackageGS110In Commercial Distribution
20192253020127PrimaryGS10
10192253020120Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225302012850192253020128
2019225302012720192253020127
1019225302012010192253020120

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10080196163885MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
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10884389110010MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110072MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
00634916797114Reusable Gown STANDARD TEXTILE CO., INC.OEA2026-03-11
00634916797121Reusable GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916797459ComPel Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916881356Reversible Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916881363Reversible Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
10810132044356HCSConcordance Healthcare Solutions LLCOEA2026-03-09
20810132044360HCS SourcingConcordance Healthcare Solutions LLCOEA2026-03-09
40080196765523MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-05
10197344158881MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158904MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
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