FDA.reportPublic FDA data

HYGITECH

Primary DI
03615140002783
Brand
HYGITECH
Company
HYGITECH
Model
HY-138
Catalog number
HY-138
Device description
The sterile sleeve provides excellent protection for tubing while guaranteeing the best sanitary conditions.It is easy to put on and fix.
Published
2020-11-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FXPCover, Shoe, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615140002790PackageGS110In Commercial Distribution
03615140002806PackageGS116In Commercial Distribution
03615140002783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615140002790036151400027903615140002790
03615140002806036151400028063615140002806
03615140002783036151400027833615140002783

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.

Regulatory Flags#

DUNS number
279456896
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03615140002875HYGITECHHY-064HY-0642020-12-15
03615140002899HYGITECHHY-066HY-0662020-12-15
03615140003247HYGITECHHY-50013HY-500132020-12-15
03615140003568HYGITECHHY-50018HY-500182020-12-15
03615140003612HYGITECHHY-50016HY-500162020-12-15
03615140003728HYGITECHHY1-630HY1-6302020-10-13
03615140000116HYGITECHHY-90078HY-900782020-12-14
03615140000307HYGITECHHY-057HY-0572020-12-15
03615140000321HYGITECHHY-055HY-0552020-12-15
03615140002721HYGITECHHY-05702HY-057022020-12-15
03615140002837HYGITECHHY-060HY-0602020-12-15
03615140002851HYGITECHHY-062HY-0622020-12-15
03615140002561HYGITECHHY-130012HY-1300122020-11-24
03615140002592HYGITECHHY-130025HY-1300252020-12-15
03615140004534HYGITECHHY-130014HY-1300142020-12-16
03615140003261HYGITECHHY-50015HY-500152020-12-15
03615140003094HYGITECHHY-525HY-5252020-11-25
03615140003124HYGITECHHY-604HY-6042020-11-25
03615140003155HYGITECHHY-607HY-6072020-11-25
03615140003186HYGITECHHY-60033HY-600332020-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30080196291513MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
30080196300901MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
30080196300918MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
30080196303599MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
30080196720174MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
30080196721751MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
30884389141810MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-09-22
00840456217566JMUJMU DENTAL, INCFXP2026-07-07
00860012300792JMUJMU DENTAL, INCFXP2026-07-07
00199536901209BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901216BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901223BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901230BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901247BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901254BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901261BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901278BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
20197344164049MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-30
20197344133120MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
20197344151575MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
10197344103973MEDLINEMEDLINE INDUSTRIES, INC.FXP2025-04-05
10810141933214VIVIT SupplyVivit Supply LLCFXP2024-11-29
10810141933221VIVIT SupplyVivit Supply LLCFXP2024-11-29
10850053289504SURGYCOSurgyco LLCFXP2024-08-09
20197344036117MedlineMEDLINE INDUSTRIES, INC.FXP2024-02-16
20197344074454MedlineMEDLINE INDUSTRIES, INC.FXP2024-02-16
20197344036049MedlineMEDLINE INDUSTRIES, INC.FXP2024-01-01
20197344036056MedlineMEDLINE INDUSTRIES, INC.FXP2024-01-01
20197344029607MedlineMEDLINE INDUSTRIES, INC.FXP2023-12-22
20197344029614MedlineMEDLINE INDUSTRIES, INC.FXP2023-12-19