FDA.reportPublic FDA data

Resilient Medical Solutions

Primary DI
00850061262929
Brand
Resilient Medical Solutions
Company
Resilient Medical Solutions, LLC
Model
RMAM1YXL
Device description
AAMI 1 Fullback Gown, Over-the-Head, Thumbloop Elastic Cuff, Yellow, XL
Published
2025-05-16
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
OEANon-Surgical Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850061262926PackageGS1100In Commercial Distribution
00850061262929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006126292610850061262926
00850061262929008500612629298500612629290850061262929

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
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850061262912Resilient Medical SolutionsRMAM1YU2025-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
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10197106988176CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-13
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10197106824832CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
10197106860120CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
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10197106861936CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
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10197106779781CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
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10197106835029CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-19
10197106835128CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-18
10197106720950CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106720974CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721032CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106746011CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106833490CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106785140CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106827802CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106829097CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106818862CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-05
10197106820759CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-29
10197106741979CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-11
10197106472408CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106796115CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106743669CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26
10197106744192CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26