FDA.reportPublic FDA data

Gredale USA-Made AAMI Level 2 Isolation Gown (Large)

Primary DI
10860008925708
Brand
Gredale USA-Made AAMI Level 2 Isolation Gown (Large)
Company
Gredale LLC
Model
GRE2000-L
Device description
Gredale USA-Made AAMI Level 2 Isolation Gown (Large)
Published
2022-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860008925705PackageGS110In Commercial Distribution
10860008925708PrimaryGS10
00860008925701Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086000892570520860008925705
1086000892570810860008925708
00860008925701008600089257018600089257010860008925701

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.

Contacts#

Phone, Email table
PhoneEmail
(323) 210-3951shop@gredale.com

Regulatory Flags#

DUNS number
079303209
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860008925722Gredale USA-Made AAMI Level 1 Isolation Gown (Large)GRE1000-L2022-08-23
10860008925739Gredale USA-Made AAMI Level 1 Isolation Gown (X-Large)GRE1000-XL2022-08-23
10860008925746Gredale USA-Made AAMI Level 3 Surgical Gown (Large)GRE3000-L2022-08-23
10860008925753Gredale USA-Made AAMI Level 3 Surgical Gown (X-Large)GRE3000-XL2022-08-23
20860008925729Gredale USA-Made AAMI Level 1 Isolation Gown (Large)GRE1000-L2022-08-23
20860008925736Gredale USA-Made AAMI Level 1 Isolation Gown (X-Large)GRE1000-XL2022-08-23
20860008925743Gredale USA-Made AAMI Level 3 Surgical Gown (Large)GRE3000-L2022-08-23
20860008925750Gredale USA-Made AAMI Level 3 Surgical Gown (X-Large)GRE3000-XL2022-08-23
10860008925715Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large)GRE2000-XL2022-07-12
20860008925705Gredale USA-Made AAMI Level 2 Isolation Gown (Large)GRE2000-L2022-07-12
20860008925712Gredale USA-Made AAMI Level 2 Isolation Gown (X-Large)GRE2000-XL2022-07-12

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