FDA.reportPublic FDA data

PRIMED

Primary DI
00842942017247
Brand
PRIMED
Company
priMED Medical Products Inc
Model
PM4-68394
Device description
Overhead AAMI 4 Open Back Gown, Knit Cuff, Blue, Universal.
Published
2025-07-15
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
FYAGown, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842942017244PackageGS110In Commercial Distribution
00842942017247PrimaryGS10
90842942017240Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084294201724410842942017244
00842942017247008429420172478429420172470842942017247
9084294201724090842942017240

GMDN Terms#

Term, Definition table
TermDefinition
Bone-conduction hearing aid, head-wornAn electrically-powered, external, acoustic device intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, through the skull to the inner ear. It typically incorporates a microphone, amplifier, and vibrator mounted or magnetically connected to a head-worn device (e.g., headband or spectacles); it may include positioning and protection devices. The microphone receives sound waves and converts them into electrical signals sent to the vibrator which transmits vibrations, typically through the mastoid bone, to the inner ears for hearing. This device is typically used to treat hearing impairment due to middle and/or outer ear obstructive pathologies.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, and well ventilated space out of direct sunlight.

Regulatory Flags#

DUNS number
253287569
Device count
10
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
00842942013485PRIMEDPM1-33542026-06-04
00842942013645PRIMEDPM1-34242026-06-04
00842942013652PRIMEDPM1-34362026-06-04
00842942013669PRIMEDPM1-34402026-06-04
00842942013676PRIMEDPM1-34452026-06-04
00842942013683PRIMEDPM1-34482026-06-04
00842942014888PRIMEDPM1-33722026-06-04
00842942014895PRIMEDPM1-34182026-06-04
00842942014901PRIMEDPM1-34302026-06-04
00842942014918PRIMEDPM1-34542026-06-04
00842942014970PRIMEDPM1-35182026-06-04
00842942014987PRIMEDPM1-35242026-06-04
00842942014994PRIMEDPM1-35302026-06-04
00842942015007PRIMEDPM1-35362026-06-04
00842942015014PRIMEDPM1-35452026-06-04
00842942015021PRIMEDPM1-35482026-06-04
00842942015038PRIMEDPM1-35542026-06-04
00842942015045PRIMEDPM1-35722026-06-04
00842942015052PRIMEDPM1-36362026-06-04
00842942015069PRIMEDPM1-36402026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918123325AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-06-04
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
20888277720050MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-11
20888277419879MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277419886MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277660905MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674704MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674711MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674728MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277674735MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
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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07613327625219Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625226Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625240Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625257Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
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07613327625288Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625295Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625301Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625318Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21