FDA.reportPublic FDA data

Resilient Medical Solutions

Primary DI
00850037100415
Brand
Resilient Medical Solutions
Company
Resilient Medical Solutions, LLC
Model
RMIN21
Device description
Knit Pants, Washable - 2XL/3XL, Waist 39-59 in (100-150 cm), 4 bags/case
Published
2023-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EYQGarment, Protective, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850037100412PackageGS14In Commercial Distribution
00850037100415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003710041210850037100412
00850037100415008500371004158500371004150850037100415

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence pants, reusableAn underwear intended to help manage urine and/or stool leakage in incontinent adults and older children. It typically consists of a man’s brief or woman’s panty with external softness and shape resembling regular underwear; some types have a liner, or are designed with an integrated opening to allow the passage of stool into an disposable collection bag/pouch via a flange or noninvasive tube; the collection pouch may be supplied with the pants. The device is intended to be used by patients in healthcare facilities and at home or similar environment. This is a reusable device.

Regulatory Flags#

DUNS number
076404432
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00850037100408Resilient Medical SolutionsRMIN202023-03-13
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

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Primary DI, Brand, Company table
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