FDA.report

HENRY SCHEIN

Primary DI
20304040139367
Brand
HENRY SCHEIN
Company
HENRY SCHEIN, INC.
Model
5702358
Catalog number
5702358
Device description
Isolation Gowns AAMI 1 Yellow Medium
Published
2021-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
20304040139367PackageGS110In Commercial Distribution
10304040139360PrimaryGS10
00304040139363Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404013936720304040139367
1030404013936010304040139360
00304040139363003040401393633040401393630304040139363

GMDN Terms

TermDefinition
Isolation gown, reusableA 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 reusable garment intended to be laundered after each use.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00keep away from sunlight, keep dry.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
10
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10080196163885MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110003MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
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
10197344158928MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158942MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158966MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158997MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159000MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159024MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159031MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159048MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159055MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159062MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159079MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159086MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159093MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159116MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159123MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344200474MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03