FDA.reportPublic FDA data

Medline

Primary DI
10080196764037
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJP4114
Catalog number
DYNJP4114
Device description
DRAPE,FEM ANGIO,POUCH,STERILE
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KKXDrape, surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196764038PackageGS110In Commercial Distribution
10080196764037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019676403840080196764038
1008019676403710080196764037

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The contents of this package may burn if exposed to a flame or extremely hot objext. Avoid contact with an open flame or high intensity heat.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196316809MedlineMSC8722EPMSC8722EP2023-08-15
10080196316816MedlineMSC8744EPMSC8744EP2023-08-15
10193489081053MedlineMSC8422MSC84222023-08-15
10193489081060MedlineMSC8444MSC84442023-08-15
10197344039821MEDLINEHNY19075HNY190752024-10-11
10884389122952MedlineMSC871X8EPMSC871X8EP2023-08-15
10884389155448MedlineMSC8488MSC84882023-08-15
10888277720749MedlineMSC8722EPFMSC8722EPF2023-08-04
10888277720756MedlineMSC8744EPFMSC8744EPF2023-08-04
10080196180639GeminiGEM1115SGEM1115S2020-12-22
00080196749884MEDLINEMDS149010MDS1490102024-03-05
00080196749891MEDLINEMDS149000MDS1490002021-09-09
10080196418329MEDLINEHCS4482RHCS4482R2021-03-31
10080196418336MEDLINEHCS4483RHCS4483R2020-12-01
10080196715534HUDSON RCIHCS4482HCS44822021-03-31
10080196715565MEDLINEHCS4486HCS44862021-03-31
10888277657625MEDLINEHCSU4483HCSU44832021-10-01
10888277699205MEDLINEHCS4481VTHCS4481VT2021-10-01
10888277699229MEDLINEHCS4483VTHCS4483VT2021-10-01
10888277699236MEDLINE INDUSTRIESHCSU448314HCSU4483142021-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628110259448MolecuLightDX Sterile Surgical Sleeve Convenience Kit of 25MolecuLight IncKKX2026-07-08
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10812564036022MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036077MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036107MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036183MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036190MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036213MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036381MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20080196017017MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277636726MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660943MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660950MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
40884389185781MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277635552MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
40888277357038MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
06975085709480Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2024-07-12
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496655Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497195Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497720Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29