FDA.report

Medline

Primary DI
20193489136118
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJP2201SG
Catalog number
DYNJP2201SG
Device description
GOWN,SIRUS,POLYRNF,SETINSLV,L,20/CS
Published
2023-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FYAGOWN, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489136118PackageGS120In Commercial Distribution
10193489136111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348913611820193489136118
1019348913611110193489136111

GMDN Terms

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.

Storage And Handling

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

Sterilization Methods

Method

Contacts

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
true
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

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30193489036248MEDLINEMDSE2RDCPMDSE2RDCP2022-12-10
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40888277170972MEDLINEFG1503FG15032026-03-20
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40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

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
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