FDA.reportPublic FDA data

A Plus

Primary DI
00683534060377
Brand
A Plus
Company
A PLUS INTERNATIONAL INC.
Model
1
Catalog number
68-571W-L
Device description
APRON, LAM, WHITE;10/BG, 100/CS
Published
2022-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80683534060373PackageGS1100In Commercial Distribution
00683534060377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8068353406037380683534060373
00683534060377006835340603776835340603770683534060377

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
191705904
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00683534820513A Plus19206-JB2022-10-19
00683534820544A Plus1OR-1740-JB2022-10-19
00683534040010A Plus144-0040-8718-32024-01-18
00683534040027A Plus144-0040-8719-12024-01-18
00683534040034A Plus170-2004-4277-32024-01-18
00683534090336RegardA3PMSKUL4-REG2025-08-06
00683534090343RegardA3PMSKUL4-REG2025-08-06
00683534850015A Plus1SEP1525-12022-10-19
00683534850022A Plus1SNA0304-12022-10-19
00683534850039A Plus1SAB0810-12022-10-19
00683534850046A Plus1SAB0875-12022-10-19
00683534850053A Plus1AB0509-N2022-10-19
00683534850060A Plus1AB0810-N2022-10-19
00683534850077A Plus1AB0875-N2022-10-19
00683534850084A Plus1NG-2204-32022-10-19
00683534850091A Plus1NG-3304-32022-10-19
00683534850107A Plus1NG-4404-32022-10-19
00683534850114A Plus1SDR4406-22022-10-19
00683534850121A Plus1SIV2206-22022-10-19
00683534850138A Plus1NG-2203-32022-10-19

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