FDA.reportPublic FDA data

BGEcare

Primary DI
00850006820276
Brand
BGEcare
Company
Boston Bgecare Inc
Device description
Zhende AAMI3 Surgical Gown with Reinforcement, 45g/m2 SMS, Level 3, AAMI3,FDA Registered, 26 Packs, Size XL
Published
2023-11-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FYAGown, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006820276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006820276008500068202768500068202760850006820276

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056757726
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810116271818BGEcareIsland Dressing2023-11-20
00850006820009BGEcare2023-11-20
00850006820016BGEcare2023-11-20
00850006820023BGEcare2023-11-20
00850006820030BGEcare2023-11-20
00850006820047BGEcare2023-11-20
00850006820054BGEcare2023-11-20
00850006820078BGEcare2023-11-20
00850006820085BGEcare2023-11-20
00850006820092BGEcare2023-11-20
00850006820108BGEcare2023-11-20
00850006820115BGEcare2023-11-20
00850006820122BGEcare2023-11-20
00850006820139BGEcare2023-11-20
00850006820146BGEcare2023-11-20
00850006820153BGEcare2023-11-20
00850006820061Zhende2023-11-18
00850006820252zhende2023-11-19
00810116271825BGEcareIsland Dressing2023-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518442430SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442447SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
09009607822207ViVi TOGA Premium Size XL-XXLTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607822214ViVi TOGA Premium Size M-LTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607822221ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832206ViVi TOGA Premium Size XL-XXLTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832213ViVi TOGA Premium Size M-LTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832220ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
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