FDA.reportPublic FDA data

Medegen Medical Products, LLC

Primary DI
00700812009405
Brand
Medegen Medical Products, LLC
Company
MEDEGEN MEDICAL PRODUCTS, LLC
Model
3909
Device description
Cover: Stretcher 39x111 2.35Ml Clr 40
Published
2020-09-20
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
KMEBEDDING, DISPOSABLE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00700812009405PrimaryGS10
10700812009402Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00700812009405007008120094057008120094050700812009405
1070081200940210700812009402

GMDN Terms#

Term, Definition table
TermDefinition
Basic bed sheet, single-useA large piece of fabric material intended to cover the mattress of a bed to protect it from being soiled and to provide the bed's occupant with clean, non-irritating contact surfaces (over and under); it does not include antimicrobial or nonadherent properties. It is typically made of a thin-textile or reinforced-paper material. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).

Regulatory Flags#

DUNS number
055527753
Device count
40
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00700812001201Medegen MedicalH140-01H140-012020-05-18
00700812001218Medegen Medical ProductsH140CR-01H140CR-012020-05-18
00700812001225Medegen Medical ProductsH140D-01H140D-012020-05-18
00700812001232Medegen Medical ProductsH141-01H141-012020-05-18
00700812001263Medegen Medical Products, LLCH149-012020-12-20
00700812003892Medegen Medical Products, LLC25652020-12-20
H3621580Medegen Medical products1581582016-09-23
H362158TY0Medegen Medical products158TY158TY2016-09-23
H362158V0Medegen Medical products158V158V2016-09-23
H3621780Medegen Medical products1781782016-09-23
H362178TY0Medegen Medical products178TY178TY2016-09-23
H362178V0Medegen Medical products178V178V2016-09-23
H3621800Medegen Medical products1801802016-09-23
H362180S0Medegen Medical products180S180S2016-09-23
H362180TY0Medegen Medical products180TY180TY2016-09-23
H362180V0Medegen Medical products180V180V2016-09-23
H3621820Medegen Medical products1821822016-09-23
H362182S0Medegen Medical products182S182S2016-09-23
H362182TY0Medegen Medical products182TY182TY2016-09-23
H362182V0Medegen Medical products182V182V2016-09-23

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Primary DI, Brand, Company table
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04260647540369TECOtherm Wrabbit +transTec Com Medizintechnik GmbHKME2026-08-26
00199972000535CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00199972000559CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00199972000573CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00840117349551Drape Sheets, Polypropylene/Polyethylene 2-ply, Black, 40" x 90" (101.6 cm x 228Dynarex CorporationKME2026-07-31
00840117350069Pillow Cases, Polypropylene/Polyethylene 2-ply, Black, 21" x 30"Dynarex CorporationKME2026-07-31
00840456201435JMUJMU DENTAL, INCKME2026-07-06
00840456206362JMUJMU DENTAL, INCKME2026-07-06
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)Dynarex CorporationKME2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)Dynarex CorporationKME2026-06-08
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
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00199536911161BluelineTransparent Supply Solutions Ltd.KME2026-05-15
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10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19