FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
20888277677972
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJE4350
Catalog number
DYNJE4350
Device description
DRAPE, ROBOTIC ARM, STERILE, 15X70"
Published
2021-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMPCover, barrier, protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMPCover, Barrier, ProtectiveGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277677972PackageGS125In Commercial Distribution
10888277677975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827767797220888277677972
1088827767797510888277677975

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814707023817ProtekASPEN SURGICAL PRODUCTS, INC.MMP2026-02-16
00850061871053IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMP2024-10-23
00850061871039IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMP2024-10-22
40193489130226COLABELMEDLINE INDUSTRIES, INC.MMP2024-04-11
40884389413631Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
40884389413648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
40884389614601Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
40195327422203Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-06-04
10193489189223MedlineMEDLINE INDUSTRIES, INC.MMP2022-11-10
40080196900702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489469456Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489490498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771443Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771467Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771474Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771481Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327052585Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327057405Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327057658Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327057665Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327060085Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
M7521001NS1Stradis Medical, LLC.STRADIS MEDICAL, LLCMMP2022-04-26
10810050854174Typenex Extubation BibTYPENEX MEDICAL LLCMMP2022-04-04
00850977007881IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMP2021-12-14
40195327004409Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2021-10-03
10193489400625Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2021-07-04
40193489437127MedlineMEDLINE INDUSTRIES, INC.MMP2021-02-11
40080196073161MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-31
40080196001805MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-23