FDA.reportPublic FDA data

Medline

Primary DI
40080196723134
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJP2000
Catalog number
DYNJP2000
Device description
GOWN,SLEEVE,STERILE,W/CSR WRAP,1/P
Published
2016-10-14
Public version status
Update
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
FYAGOWN, SURGICAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196723134PackageGS160In Commercial Distribution
10080196723133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019672313440080196723134
1008019672313310080196723133

GMDN Terms#

Term, Definition table
TermDefinition
Surgical sleeve coverA forearm covering made of non-woven synthetic fabric materials intended to be worn over a scrub suit by healthcare staff during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid contact with an open flame or high intensity heat source

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
true
Premarket exempt
false
HCT/P
false
Kit
true
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
00634916349740Compel MLR OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916788105Compel MLR OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916788112Compel MLR OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916788129Compel MLR OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916789249ProMax Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916789256ProMax Surgical Gown,STANDARD TEXTILE CO., INC.FYA2026-03-11
00634916789263ProMax Surgical Gown,STANDARD TEXTILE CO., INC.FYA2026-03-11
00634916792775OR GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916796322ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916796339ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916796346ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916829358ProMax Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916880205ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916880816ComPel Surgical Gown,STANDARD TEXTILE CO., INC.FYA2026-03-11
00634916880823ComPel Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
00634916899627ProMax Surgical GownSTANDARD TEXTILE CO., INC.FYA2026-03-11
10888277720053MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-11
10888277419872MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10888277419889MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10888277660908MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10888277674707MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10888277674714MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10888277674721MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10888277674738MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
10193489021820MedlineMEDLINE INDUSTRIES, INC.FYA2026-02-11
10193489040111MedlineMEDLINE INDUSTRIES, INC.FYA2026-02-11
10197344014002MedlineMEDLINE INDUSTRIES, INC.FYA2026-02-11
06931747835652ZDXuchang Zhengde Environstar Medical Products Co., Ltd.FYA2026-02-01
20197344179760MEDLINEMEDLINE INDUSTRIES, INC.FYA2026-01-29
00850078013002MAXAIRSyntech, Int'l Inc.FYA2026-01-14