FDA.report

HENRY SCHEIN

Primary DI
20304040140271
Brand
HENRY SCHEIN
Company
HENRY SCHEIN, INC.
Model
5702371
Catalog number
5702371
Device description
Isolation Gowns AAMI 3 Blue 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
FYCGown, isolation, surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FYCGown, Isolation, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20304040140271PackageGS110In Commercial Distribution
10304040140274PrimaryGS10
00304040140277Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404014027120304040140271
1030404014027410304040140274
00304040140277003040401402773040401402770304040140277

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

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