FDA.reportPublic FDA data

Resilient Medical Solutions

Primary DI
00850061262196
Brand
Resilient Medical Solutions
Company
Resilient Medical Solutions, LLC
Model
RMISOLV3XL
Device description
Full Back, AAMI 3, OTH, Thumbloop, Elastic Cuffs, XL 10/bg, 10 bgs/cs
Published
2025-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FYCGown, Isolation, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYCGown, Isolation, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850061262193PackageGS1100In Commercial Distribution
00850061262196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006126219310850061262193
00850061262196008500612621968500612621960850061262196

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
076404432
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850086117037Resilient Medical SolutionsRMTMDBG2026-07-08
00850061262936Resilient Medical SolutionsRMEG12502026-05-20
00850061262943Resilient Medical SolutionsRMEG22502026-05-20
00850061262950Resilient Medical SolutionsRMEG32502026-05-20
00850061262967Resilient Medical SolutionsRMEG42502026-05-20
00850061262974Resilient Medical SolutionsRMEG52302026-05-20
00850061262981Resilient Medical SolutionsRMEM1Y2026-05-20
00850061262998Resilient Medical SolutionsRMEM1F2026-05-20
00850086117006Resilient Medical SolutionsRMEM22026-05-20
00850086117013Resilient Medical SolutionsRMTM1AFB2026-05-20
00850086117020Resilient Medical SolutionsRMTM3AFB2026-05-20
00850037100507Resilient Medical SolutionsRMTD12023-08-16
00850037100514Resilient Medical SolutionsRMTD22023-08-16
00850037100521Resilient Medical SolutionsRMSH3L2023-07-31
00850037100538Resilient Medical SolutionsRMSH5L2023-07-31
00850037100545Resilient Medical SolutionsRMSH10L2023-07-31
00850037100552Resilient Medical SolutionsRMSH20L2023-07-31
00850037100569Resilient Medical SolutionsRMSH50L2023-07-31
00850061262899Resilient Medical SolutionsRMTMDBS32025-05-16
00850061262905Resilient Medical SolutionsRMSOTHYU2025-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813360021475ProtexerICP MEDICAL, LLCFYC2025-08-15
10813360021472ProtexerICP MEDICAL, LLCFYC2025-08-15
00813360021468ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162000030ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162290004ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162390506ProtexerICP MEDICAL, LLCFYC2025-08-08
10813360021465ProtexerICP MEDICAL, LLCFYC2025-08-08
00813360021772ProtexerICP MEDICAL, LLCFYC2025-08-08
00842942015175PRIMEDpriMED Medical Products IncFYC2025-07-21
00842942015304PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015172PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015301PRIMEDpriMED Medical Products IncFYC2025-07-21
04719882251399CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251412CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
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14719882251433CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251457CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251556CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251570CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16